Alpha 2 Agonists for Sedation to Produce Better Outcomes From Critical Illness (A2B Trial) (A2B)

October 1, 2024 updated by: University of Edinburgh

Alpha 2 Agonists for Sedation to Produce Better Outcomes From Critical Illness (A2B Trial): A Randomised, Parallel-group, Allocation Concealed, Controlled, Open, Phase 3 Pragmatic Clinical and Cost- Effectiveness Trial With Internal Pilot

Many patients in intensive care (ICU) need help to breathe on a breathing machine and need pain killers and sedatives to keep them comfortable and pain free. However, keeping patients too deeply sedated can make their ICU stay longer, can cause ICU confusion (delirium) and afterwards may cause distressing memories. Ideally patients should be kept less sedated, but it is difficult to get the balance of sedation and comfort right.

The investigators want to know whether starting an alpha2-agonist drug early in ICU can help keep patients more lightly sedated but still comfortable, and whether patients spend less time on the ventilator. The investigators also want to know how safe they are and if they can improve important outcomes during ICU stay and during recovery. The investigators also want to know if they are value for money.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Many patients in intensive care (ICU) need help to breathe on a breathing machine and need pain killers and sedatives to keep them comfortable and pain free. However, keeping patients too deeply sedated can make their ICU stay longer, can cause ICU confusion (delirium), and afterwards may cause distressing memories. Ideally, the investigators want to keep patients less sedated, but it is difficult to get the balance of sedation and comfort right.

For sedation, most ICUs use a drug called 'propofol' that is good at reducing anxiety and making people sleepy, but is not a pain killer, so additional pain killers are needed. There are two other drugs used less often called 'alpha-2 agonists' that have both sedative and pain-killing actions, which may make it easier for patients to be more awake and comfortable on the ventilator. The two drugs are called clonidine and dexmedetomidine.

The investigators want to know whether starting an alpha2-agonist drug early in ICU, and using this instead of propofol as much as possible, can help keep patients more lightly sedated but still comfortable, and whether patients spend less time on the ventilator with these drugs. The investigators also want to know how safe these drugs are and if improve important outcomes during ICU stay can be improved (like delirium, comfort, and safety) and during recovery (like bad memories, anxiety, and depression). The investigators also want to know if they are value for money.

The trial will include 1437 participants needing to be on a ventilator for at least 2 days. Participants will be allocated to one of three groups by chance. One group will continue to receive propofol; one group will receive dexmedetomidine; and one group will receive clonidine. All participants will receive extra pain relief if needed, and participants in the dexmedetomidine and clonidine groups will continue to receive propofol if they need this in addition. Nurses and doctors will alter the doses of sedation drugs to try and reduce or stop them, but always aiming to have participants lightly sedated and comfortable. The trial will compare if participants on dexmedetomidine or clonidine come off the ventilator quicker than those just on propofol. The trial will examine whether there was a difference between the groups in the number of participants who experienced delirium in ICU, compare how comfortable participants were, and measure if participants memories of being in the ICU differed.

Patients who were in the trial will be followed up for up to 180 days afterwards because the investigators want to compare if there were differences in the after-effects of being ill in ICU between the groups. Participants will be asked to complete questionnaires that will assess their memories of the ICU experience at 90 days after entering the trial. At 180 days, participants will be asked to complete questionnaires so that the investigators can detect how patients feel about their quality of life or if they suffer from anxiety, depression or stress. Note that for patients recruited during the final months of recruitment, the 90 and 180 days follow will be truncated and not collected. This was agreed with the TSC and funder to reduce trial costs and enable trial completion.

Alongside this trial, investigators will be looking at value for money, which is important because clonidine, dexmedetomidine, and propofol costs are quite different. Clonidine, in particular, is relatively inexpensive. ICU nurses' and doctors' views on how easy or difficult it was to adjust and use the drugs will be obtained. This will give valuable practical information that can be shared with other ICUs, particularly if alpha2-agonists are found to be better and other ICUs want to start using them.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1437

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Belfast, United Kingdom
        • Belfast Health & Social Care Trust
      • Belfast, United Kingdom
        • South Eastern Health and Social Trust
      • Birmingham, United Kingdom
        • University Hospitals Birmingham NHS Foundation Trust
      • Blackpool, United Kingdom
        • Blackpool Teaching Hospitals NHS Foundation Trust
      • Bristol, United Kingdom
        • University Hospitals Bristol NHS Foundation Trust
      • Bristol, United Kingdom
        • North Bristol NHS Trust
      • Cambridge, United Kingdom
        • Cambridge University Hospitals NHS Foundation Trust
      • Cardiff, United Kingdom
        • Cardiff and Vale University Health Board
      • Chester, United Kingdom
        • COUNTESS OF CHESTER HOSPITAL NHS FOUNDATION TRUST
      • Dudley, United Kingdom
        • The Dudley Group NHS Foundation Trust
      • Dumfries, United Kingdom
        • NHS Dumfries and Galloway
      • Edinburgh, United Kingdom
        • NHS Lothian
      • Gillingham, United Kingdom
        • Medway NHS Foundation Trust
      • Glasgow, United Kingdom
        • NHS Greater Glasgow and Clyde
      • Harrogate, United Kingdom
        • Harrogate and District NHS Trust
      • Hereford, United Kingdom
        • Wye Valley NHS Trust
      • King's Lynn, United Kingdom
        • The Queen Elizabeth Hospital Kings Lynn NHS Foundation Trust
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust
      • Leicester, United Kingdom
        • University Hospitals of Leicester
      • Lewisham, United Kingdom
        • Lewisham and Greenwich NHS Trust
      • Liverpool, United Kingdom
        • Royal Liverpool and Broadgreen University Hospitals NHS Trust
      • Liverpool, United Kingdom
        • Aintree University Hospital Foundation Trust
      • London, United Kingdom
        • University College London Hospitals NHS Foundation Trust
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom
        • King's College Hospital NHS Foundation Trust
      • London, United Kingdom
        • St George's University Hospitals NHS Foundation Trust
      • London, United Kingdom
        • The Royal Marsden NHS Foundation Trust
      • London, United Kingdom
        • Guys and St Thomas NHS Foundation Trust
      • Manchester, United Kingdom
        • Manchester University Foundation Trust
      • Newcastle, United Kingdom
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
      • Newport, United Kingdom
        • Aneurin Bevan University Health Board
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust
      • Oxford, United Kingdom
        • Oxford University Hospitals NHS Foundation Trust.
      • Poole, United Kingdom
        • Poole Hospitals NHS Foundation Trust
      • Southampton, United Kingdom
        • University Hospital Southampton NHSFT
      • Stockton-on-Tees, United Kingdom
        • North Tees and Hartlepool NHS Foundation Trust
      • Taunton, United Kingdom
        • Taunton and Somerset NHS Foundation Trust
      • Watford, United Kingdom
        • West Hertfordshire Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient requiring mechanical ventilation (MV) in an ICU
  2. Aged 18 or over
  3. Within 48 hours of first episode of mechanical ventilation in ICU
  4. Requiring sedation with propofol
  5. Expected to require a total of 48 hours of MV or more in ICU
  6. Expected to require a further 24 hours of MV or more at the time of randomisation in the opinion of the responsible clinician

Exclusion Criteria:

  1. Acute brain injury (traumatic brain injury; intracranial haemorrhage; ischaemic brain injury from stroke or hypoperfusion)
  2. Post-cardiac arrest (where there is clinical concern about hypoxic brain injury)
  3. Status epilepticus
  4. Continuous therapeutic neuromuscular paralysis at the time of screening or randomisation
  5. Guillain-Barre Syndrome
  6. Myasthenia gravis
  7. Home ventilation
  8. Fulminant hepatic failure
  9. Patient not expected to survive 24 hours by responsible clinician
  10. Decision to provide only palliative or end-of-life care
  11. Pregnancy
  12. Known allergy to one of the study drugs
  13. Untreated second or third degree heart block
  14. Transferred from another Intensive Care Unit in which MV occurred for >6 hours
  15. Prisoners
  16. Enrolled on another CTIMP
  17. Previously enrolled on the A2B Trial
  18. Patient known to have experienced a period with heart rate <50 beats per minute for 60 minutes or longer since commencing mechanical ventilation in the ICU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Care (Propofol) Group
Usual Care Group : Patients will continue to receive intravenous propofol according to usual current care . The sedation targets, weaning, and sedation discontinuation procedures will follow the same clinical targets as for the clonidine and dexmedetomidine groups.
Drug: Propofol
Patients will continue to receive intravenous propofol according to current usual care.
Other Names:
  • Diprivan
Experimental: Dexmedetomidine Group
For dexmedetomidine, the regimen will follow the manufacturer's guidance and regimens used in previous trials. Dexmedetomidine will be up and down titrated against sedation targets set by clinical staff and reviewed at regular intervals, and documented at least daily. No loading dose will be administered. The starting dose will be 0.7 µg.kg-1.hour-1 titrated to a maximum dose 1.4 µg.kg-1 hour-1. Lower starting doses will be used at clinical discretion for patients with cardiovascular instability.
Drug: Dexmedetomidine

Patients will commence intravenous infusion of open-label study drug according to a weight-based dose regimen as early as possible post-randomisation, and within a maximum of two hours.

Bedside clinical staff will transition patients to achieve sedation with the allocated α2-agonist agent as quickly as clinically feasible and safe, to replicate the way these drugs would be used in routine practice. Additional opiate will be used for analgesia using clinical judgement. Once established, additional propofol will only be used when the maximum α2-agonist dose is reached or because cardiovascular or other side-effects limit dose escalation.

Other Names:
  • Dexdor
Experimental: Clonidine Group
For clonidine, the regimen is designed to be equipotent with dexmedetomidine based on known pharmacokinetics and pharmacodynamics. The chosen regimen is similar to that currently used in many UK ICUs as part of routine 'off label' practice. Clonidine will be up and down titrated against sedation targets set by clinical staff and reviewed at regular intervals, and at least daily. No loading dose will be administered. The starting dose will be 1.0µg.kg-1.hour-1 titrated to a maximum dose of 2 µg.kg-1.hour-1. Lower starting doses will be used at clinical discretion for patients with cardiovascular instability.
Drug: Clonidine

Patients will commence intravenous infusion of open-label study drug according to a weight-based dose regimen as early as possible post-randomisation, and within a maximum of two hours.

Bedside clinical staff will transition patients to achieve sedation with the allocated α2-agonist agent as quickly as clinically feasible and safe, to replicate the way these drugs would be used in routine practice. Additional opiate will be used for analgesia using clinical judgement. Once established, additional propofol will only be used when the maximum α2-agonist dose is reached or because cardiovascular or other side-effects limit dose escalation.

Other Names:
  • Catapres

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to first successful extubation post-randomisation (hours).
Time Frame: Ventilation status will be recorded twice daily from the date of randomisation until the date of documented successful extubation, or 180 days, whichever comes first.
How many hours are participants on the study ventilated for?
Ventilation status will be recorded twice daily from the date of randomisation until the date of documented successful extubation, or 180 days, whichever comes first.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: ICU status will be recorded daily from the date of randomisation until the date of ICU discharge, or 180 days, whichever comes first.
Number of days the participant is in ICU
ICU status will be recorded daily from the date of randomisation until the date of ICU discharge, or 180 days, whichever comes first.
Delirium prior to successful extubation
Time Frame: Delirium will be assessed twice daily during ICU stay using the Confusion-Agitation method for ICU (CAM-ICU). Delirium will be assessed from the date of randomisation until the date of ICU discharge, or 28 days, whichever comes first.
Did participants have delirium during ICU stay?
Delirium will be assessed twice daily during ICU stay using the Confusion-Agitation method for ICU (CAM-ICU). Delirium will be assessed from the date of randomisation until the date of ICU discharge, or 28 days, whichever comes first.
Duration of Delirium during ICU stay
Time Frame: Delirium will be assessed twice daily during ICU stay using the Confusion-Agitation method for ICU (CAM-ICU). Delirium will be assessed from the date of randomisation until the date of ICU discharge, or 28 days, whichever comes first.
How many days did participants have delirium during their ICU stay?
Delirium will be assessed twice daily during ICU stay using the Confusion-Agitation method for ICU (CAM-ICU). Delirium will be assessed from the date of randomisation until the date of ICU discharge, or 28 days, whichever comes first.
Sedation quality as measured by Richmond Agitation and Sedation Scale (RASS)
Time Frame: Sedation quality will be assessed 4 hourly during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Sedation quality as measured by Richmond Agitation and Sedation Scale (RASS). RASS scale ranges from -5 to +4. optimal score is between -2 and +1.
Sedation quality will be assessed 4 hourly during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Sedation quality as measured by Sedation Quality Assessment Tool (SQAT)
Time Frame: Sedation quality will be assessed daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Two components of the SQAT assessment will be used in this trial to measure sedation quality.
Sedation quality will be assessed daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Analgesia quality as measured by Richmond Agitation and Sedation Scale (RASS)
Time Frame: Analgesia quality will be assessed 4 hourly during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Quality of Analgesia measured by Richmond Agitation and Sedation Scale (RASS). RASS scale ranges from -5 to +4. optimal score is between -2 and +1.
Analgesia quality will be assessed 4 hourly during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Analgesia quality as measured by Sedation Quality Assessment Tool (SQAT)
Time Frame: Analgesia quality will be assessed daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Quality of Analgesia measured by Sedation Quality Assessment Tool (SQAT)
Analgesia quality will be assessed daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Number of hours to first optimum sedation as measured by a RASS score of -2 or greater
Time Frame: Level of sedation will be assessed 4 hourly during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Number of hours to first optimum sedation as measured by a RASS score of -2 or greater
Level of sedation will be assessed 4 hourly during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Number of days to first optimum sedation as assessed by the Sedation Quality Assessment Tool (SQAT)
Time Frame: Level of sedation will be assessed daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Number of days to first optimum sedation as assessed by the Sedation Quality Assessment Tool (SQAT)
Level of sedation will be assessed daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Ability to communicate pain
Time Frame: Ability to communicate pain will be assessed twice daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Binary assessment by bedside nurse
Ability to communicate pain will be assessed twice daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Ability to co-operate with care
Time Frame: Ability to co-operate with care will be assessed twice daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Binary assessment by bedside nurse
Ability to co-operate with care will be assessed twice daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Relative/Partner/Friend (PerLR) assessment of wakefulness
Time Frame: Participant wakefulness will be assessed by a Relative/Partner/Friend daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
PerLR response to verbal question
Participant wakefulness will be assessed by a Relative/Partner/Friend daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Relative/Partner/Friend (PerLR) assessment of patient comfort
Time Frame: Comfort of participant will be assessed by a Relative/Partner/Friend daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
PerLR response to verbal question
Comfort of participant will be assessed by a Relative/Partner/Friend daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Relative/Partner/Friend (PerLR) assessment of patient communication
Time Frame: Participant communication will be assessed by a Relative/Partner/Friend daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
PerLR response to verbal question
Participant communication will be assessed by a Relative/Partner/Friend daily during the period of ventilation from the date of randomisation until the participant is successfully extubated, or 28 days, whichever comes first.
Incidence of Drug-related adverse events - Bradycardia; hypotension; hypertension; cardiac arrhythmias; cardiac arrest
Time Frame: The incidence of drug-related adverse events as documented in the medical records will be recorded daily from the date of randomisation until the date of documented successful extubation, or 28 days, whichever comes first.
Incidence of drug-related adverse events as documented in the medical records
The incidence of drug-related adverse events as documented in the medical records will be recorded daily from the date of randomisation until the date of documented successful extubation, or 28 days, whichever comes first.
Incidence of Mortality
Time Frame: The incidence of death as documented in the medical records will be recorded from the date of randomisation until the date of the last follow-up visit at 180 days.
Mortality data collected from medical records
The incidence of death as documented in the medical records will be recorded from the date of randomisation until the date of the last follow-up visit at 180 days.
Patient experience of ICU care measured at 90 days
Time Frame: 90 days post ICU discharge
Patient experience of ICU care measured by Intensive Care Experience Questionnaire
90 days post ICU discharge
Occurrence of Anxiety and depression at 180 days
Time Frame: 180 days post ICU discharge
Patient anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS) questionnaire
180 days post ICU discharge
Occurrence of Post-traumatic stress at 180 days
Time Frame: 180 post ICU discharge
Occurence of post-traumatic stress measured by Impact of Events Scale-revised (IES-R)
180 post ICU discharge
Cognitive function assessed at 180 days using the Montreal Cognitive Assessment Tool (Postal or Telephone)
Time Frame: 180 days post ICU discharge
Cognitive function assessed at 180 days using the Montreal Cognitive Assessment Tool (Postal or Telephone)
180 days post ICU discharge
Health related Quality of Life (recalled) assessed by Euroqol tool (EQ-5D-5L)
Time Frame: 30 days post ICU discharge - recalled prior to hospital admission
Health related Quality of Life (recalled) assessed by Euroqol tool (EQ-5D-5L). Scale is between 5-25 which lower scores having the better outcome.
30 days post ICU discharge - recalled prior to hospital admission
Health related Quality of Life (30 day) assessed by Euroqol tool (EQ-5D-5L)
Time Frame: 30 days post ICU discharge
Health related Quality of Life (30 day) assessed by Euroqol tool (EQ-5D-5L). Scale is between 5-25 which lower scores having the better outcome.
30 days post ICU discharge
Health related Quality of Life (90 day) assessed by Euroqol tool (EQ-5D-5L)
Time Frame: 90 days post ICU discharge
Health related Quality of Life (90 day) assessed by Euroqol tool (EQ-5D-5L). Scale is between 5-25 which lower scores having the better outcome.
90 days post ICU discharge
Health related Quality of Life (180 day) assessed by Euroqol tool (EQ-5D-5L)
Time Frame: 180 days post ICU discharge
Health related Quality of Life (180 day) assessed by Euroqol tool (EQ-5D-5L). Scale is between 5-25 which lower scores having the better outcome.
180 days post ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Edinburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London
Imperial College London
University College, London
Queen's University, Belfast
NHS Lothian
University of Cambridge
University of Manchester
University of Warwick
Edinburgh Napier University
The University of Queensland
University Hospital of Wales
Royal Surrey County Hospital NHS Foundation Trust
West Hertfordshire Hospitals NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy Walsh, MBChB MD MSc, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC18022
  • HTA 16/93/01 (Other Grant/Funding Number: NIHR HTA Programme)
  • 2018-001650-98 (EudraCT Number)
  • 243640 (Other Identifier: Integrated Research Application System (IRAS))
  • 18/SS/0085 (Other Identifier: REC Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The final trial dataset will be held by the University of Edinburgh on a secure password protected drive. Co-investigators will have the right to access the final data set for the purpose of additional analyses that are consistent with the consent provided by participants. Similarly, any external party can approach the co-investigators to request access to the trial data. In all cases, access to the trial dataset will require approval by a majority of the members of the trial management group and the sponsor (or its delegated representative).

IPD Sharing Time Frame

Currently unknown

IPD Sharing Access Criteria

Currently unspecified

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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