Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery (COPIA)

February 23, 2021 updated by: King's College Hospital NHS Trust

Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery - a Randomised Controlled Feasibility Trial

The objective of this research proposal is to find out whether comparing the two different anaesthetic maintenance techniques (Propofol vs volatile anaesthetics) in adult patients undergoing heart surgery is practical for the anaesthetist treating the patients and whether it is feasible for the research team to recruit patients and follow them up after the operation.

Study Overview

Status

Status

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

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

All patients undergoing heart bypass surgery are given anaesthetics during the operation. There are two types of anaesthetic commonly given to patients undergoing heart bypass surgery.

Propofol is an anaesthetic that is delivered into the patient's vein. Other anaesthetics which are inhaled include Isoflurane, Sevoflurane and Desflurane and these are called volatile anaesthetics. Preliminary studies over the past ten years suggests that maintenance of general anaesthesia using only volatile anaesthetics has the potential to improve health outcomes after bypass surgery, when compared with propofol.

Volatile anaesthetics have been shown to protect the heart, the kidneys and the brain, however results of studies have been inconclusive. Currently both volatile anaesthetics and propofol are used equally in clinical practice in the UK.

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 (Anticipated)

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.
50

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 4

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
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Kings College Hospital NHS Foundation Trust
        • Contact:
          • Gudrun Kunst
        • Principal Investigator:
          • Gudrun Kunst
      • London, United Kingdom, SE1 7EH
        • Not yet recruiting
        • St Thomas' Hospital
        • Contact:
          • Martin John
        • Principal Investigator:
          • Martin John

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients (male and female) aged 18 years and above
  • Written informed consent to participate
  • Patients undergoing Coronary Artery Bypass Graft (CABG) surgery on Cardiopulmonary bypass (CPB) with or without valve surgery
  • Additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 5 or higher

Exclusion Criteria:

  • Pregnant or lactating women
  • Allergy to propofol
  • Previous diagnosis or suspected malignant hyperthermia
  • Patients with a known sensitivity to any of the IMPs or other halogenated anaesthetics
  • Concomitant therapy with glibenclamide or nicorandil (medications that may interfere with preconditioning)
  • Inclusion in another clinical trial of an investigational medicinal product within the last 3 months.

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
  • Masking: SINGLE

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: Volatile anaesthetics arm
Patients randomised to receive volatile anaesthetics will receive either isoflurane, sevoflurane or desflurane during the surgical procedure.
Drug: Isoflurane, Sevoflurane or Desflurane

The volatile anaesthetic agent will be administered via inhalation, i.e. ventilation through alveolar membrane in lungs) during the maintenance of anaesthesia. During CPB the volatile anaesthetic agent will be administered through the oxygenator oxygen inflow of the CPB machine.

The maintenance dose of the volatile anaesthetic agent will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia and blood pressure.

The administration of the volatile anaesthetic agent will be started after induction of anaesthesia and it will be ended at the end of surgery, before the patient is transferred to the CCU.
ACTIVE_COMPARATOR: Propofol anaesthetics arm
Patients randomised to receive propofol will not receive any volatile anaesthetics during the surgical procedure.
Drug: Propofol
Patients will receive propofol only during the surgical procedure. The maintenance dose of the propofol infusion will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia (titrated to a depth of anaesthesia with BIS 30-60) and mean arterial pressure (MAP) of 50-80mmHg by the treating anaesthetist.

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
Recruitment rate
Time Frame: Collected over the recruitment period of 10 months
To identify whether it is feasible to recruit up to 50 patients across 2 tertiary cardiac surgery centres within approximately 10 months.
Collected over the recruitment period of 10 months
To identify barriers to recruitment.
Time Frame: Collected over the recruitment period of 10 months
This data will be completed on a screening log.
Collected over the recruitment period of 10 months

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
Feasibility of maintaining follow-up rates of over 95%
Time Frame: Collected over the recruitment period of 10 months
This data will be gathered in the trial database.
Collected over the recruitment period of 10 months
Assessment of effectiveness of patient identification and screening processes
Time Frame: Collected over the recruitment period of 10 months
To record the number of patients screened and potentially eligible for the trial at the two tertiary cardiac surgery centres within a period of 10 months. This data will be gathered on the screening log.
Collected over the recruitment period of 10 months
To investigate whether it is feasible to recruit at least 10% of all potentially eligible patients at the two tertiary cardiac surgery centres within a period of 10 months.
Time Frame: Collected over the recruitment period of 10 months
This data will be gathered on screening logs and in the randomisation system.
Collected over the recruitment period of 10 months
To investigate whether it is feasible to maintain routine data collection and follow up rates greater than 90% over the trial period.
Time Frame: Collected over the full trial period of 24 months
This data will be gathered in the randomisation site and trial database.
Collected over the full trial period of 24 months
To investigate whether it is feasible to achieve 95% data collection of Low Cardiac Output Syndrome for the full trial over the trial period.
Time Frame: Collected over the full trial period of 24 months
This data will be gathered in the trial database.
Collected over the full trial period of 24 months
To investigate whether it is feasible to achieve 95% data collection of Myocardial injury, assessed by ischaemic serum markers: hsTnT, MyC, for the full trial over the trial period.
Time Frame: Preop, 6 hrs after arrival in CCU, and postop day 1 and 2. Collected over the full trial period of 24 months
This data will be gathered in the trial database.
Preop, 6 hrs after arrival in CCU, and postop day 1 and 2. Collected over the full trial period of 24 months
To investigate whether it is feasible to achieve 90% data collection of MACCE (stroke, non-fatal myocardial infarction, death from any cause) for the full trial over the trial period.
Time Frame: Data collected at 30 days post op.
This data will be gathered in the trial database.
Data collected at 30 days post op.
To investigate whether it is feasible to achieve 90% data collection of Cardiac related mortality at 30 days for the full trial over the trial period.
Time Frame: Data collected at 30 days post op.
This data will be gathered in the trial database.
Data collected at 30 days post op.
To investigate whether it is feasible to achieve 90% data collection of Postoperative in hospital atrial fibrillation requiring treatment for the full trial over the trial period.
Time Frame: Data collected at 30 days post op.
This data will be gathered in the trial database.
Data collected at 30 days post op.
To investigate whether it is feasible to achieve 90% data collection of Acute Kidney Injury (according to Kidney Disease: Improving Global Outcomes guidelines) for the full trial over the trial period.
Time Frame: Data collected at 30 days post op.
AKI will be confirmed by a 1.5 - 1.9 increase of serum creatinine from baseline or an absolute value rise of creatine greater than 0.3mg/dl (27mmol/L) from baseline. This data will be gathered in the trial database.
Data collected at 30 days post op.
To investigate whether it is feasible to achieve 90% data collection of In-hospital postoperative delirium (assessed by the confusion assessment method) for the full trial over the trial period.
Time Frame: Data collected at 30 days post op.
This data will be gathered in the trial database.
Data collected at 30 days post op.
To investigate whether it is feasible to achieve 90% data collection of Respiratory complications needing prolonged ventilation (>24 hours) for the full trial over the trial period.
Time Frame: Data collected at 30 days post op.
This data will be gathered in the trial database.
Data collected at 30 days post op.
To investigate whether it is feasible to achieve 90% data collection of Length of stay in the critical care unit (CCU) for the full trial over the trial period.
Time Frame: Data collected at 30 days post op.
This data will be gathered in the trial database.
Data collected at 30 days post op.
To investigate whether it is feasible to achieve 90% data collection of Length of hospital stay for the full trial over the trial period.
Time Frame: Data collected at 30 days post op.
This data will be gathered in the trial database.
Data collected at 30 days post op.
To investigate whether it is feasible to achieve 90% data collection of WHO Disability Assessment Schedule (WHODAS) for the full trial over the trial period.
Time Frame: Data collected at 30 days post op.
This data will be gathered in the trial database.
Data collected at 30 days post op.
To investigate whether it is feasible to achieve 90% data collection of Quality of Life Questionnaire (Euroqol, EQ-5D-5L) for the full trial over the trial period.
Time Frame: Data collected at Baseline and 30 days postoperative
This data will be gathered in the trial database.
Data collected at Baseline and 30 days postoperative
To investigate whether it is feasible to achieve 90% data collection of Days alive and at home for the full trial over the trial period.
Time Frame: Data collected at 30 days postoperative
This data will be gathered in the trial database.
Data collected at 30 days postoperative

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.
King's College Hospital NHS Trust

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.
London School of Hygiene and Tropical Medicine
Guy's and St Thomas' NHS Foundation 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: Dr Gudrun Kunst, King's College Hospital NHS Trust

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.
November 20, 2019

Primary Completion (ANTICIPATED)

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.
November 30, 2021

Study Completion (ANTICIPATED)

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.
January 31, 2022

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).
June 7, 2019

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.
July 30, 2019

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.
July 31, 2019

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.
February 24, 2021

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.
February 23, 2021

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.
February 1, 2021

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.
  • KCH-PRO:19/001
  • 2019-000171-16 (EUDRACT_NUMBER)
  • 216646 (OTHER: IRAS ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymous participant data may be shared with other researchers

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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