Agents Intervening Against Delirium in Intensive Care Unit (AID-ICU)

January 12, 2023 updated by: Zealand University Hospital

Agents Intervening Against Delirium in Intensive Care Unit (AID-ICU) A Randomized, Blinded, Placebo-controlled Trial

Delirium is a frequent condition in the Intensive Care Unit (ICU) with no existing evidence-based treatment. The aim of the AID-ICU study is to assess the benefits and harms of haloperidol treatment for the management of ICU acquired delirium.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

Delirium among critically ill patients in the intensive care unit (ICU) is a common condition associated with increased morbidity and mortality. No evidence-based treatment exist of this condition. Haloperidol is the most frequently used agent to treat ICU-related delirium, but according to the available literature there is no firm evidence of efficacy and safety of this intervention. AID-ICU aims to assess the benefits and harms of haloperidol in adult, critically ill patients with delirium in the ICU.

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.
1000

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 Locations

  • Denmark
      • Aabenraa, Denmark, 6200
        • Dept. Intensive Care, Aabenraa Hospital
      • Aalborg, Denmark, 9000
        • Dept. of Intensive Care, Aalborg University Hospital
      • Copenhagen, Denmark, 2100
        • Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
      • Herlev, Denmark, 2730
        • Dept. of Intensive Care, Herlev Hospital
      • Herning, Denmark, 7400
        • Dept. of Intensive Care, Herning Hospital
      • Hillerød, Denmark, 3400
        • Dept. of Intensive Care, Nordsjaelland Hospital
      • Hjørring, Denmark, 9800
        • Regionshospitalet Nordjylland, Hjørring
      • Holstebro, Denmark, 7500
        • Dept. of Intensive Care, Holstebro Hospital
      • Køge, Denmark, 4600
        • Dept. of Intensive Care, Zealand University Hospital, Køge
      • Nykøbing Falster, Denmark, 4800
        • Dept. of Intensive Care, Nykøbing Falster Hospital
      • Odense, Denmark, 5000
        • Dept of intensive care, Odense University Hospital
      • Roskilde, Denmark, 4000
        • Dept. of Intensive Care, Zealand University Hospital Roskilde
      • Sønderborg, Denmark, 6400
        • Dept. of Intensive Care, Sønderborg Hospital
  • Finland
      • Helsinki, Finland, 00120
        • Dept. of Intensive Care, Helsinki University Central Hospital
  • Italy
      • Monza, Italy
        • Dept. of Neurosurgical Intensive Care, San Gerardo Hospital, Monza.
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • UHW Adult Critical Care Cardiff

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:

  • Acute admission to the ICU AND
  • Age ≥ 18 years AND
  • Diagnosed delirium with validated screening Tool as either CAM-ICU or ICDSC

Exclusion Criteria:

  • Contraindications to haloperidol
  • Habitual treatment with any antipsychotic medication or treatment with antipsychotics in the ICU prior to inclusion
  • Permanently incompetent (e.g. dementia, mental retardation)
  • Delirium assessment non-applicable (coma or language barriers)
  • Withdrawal from active therapy
  • Fertile women (women < 50) with positive urine human chorionic gonadotropin (hCG) or plasma hCG.
  • Consent according to national regulations not obtainable
  • Patients under coercive measures by regulatory authorities
  • Patients with alcohol-induced delirium (Delirium Tremens)

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: Quadruple

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.
Experimental: Haloperidol injection

Haloperidol 2,5mg x 3 daily, with additional as needed doses to a maximum of 20mg/daily.

Other name: Serenase
Drug: Haloperidol Injection
ICU patients with diagnosed delirium are treated with 2,5mg haloperidol x 3 daily intravenously with additional as needed doses to a maximum of 20mg/daily.
Other Names:
  • Serenase
Placebo Comparator: Normal Saline
Saline (0,9%)
Other: Saline (0,9%)
ICU patients with diagnosed delirium are treated with 0,5ml isotonic saline x 3 daily and as needed doses to a maximum of 4ml/daily, corresponding to the algorithm in the experimental arm.

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
Days alive out of the hospital within 90 days post-randomization
Time Frame: 90 days
Number of days alive and out of hospital
90 days
90-day mortality
Time Frame: 90 days
Death from any cause within 90 days post-randomization
90 days
Hospital Length of Stay
Time Frame: 90 days
Total number of days the patient is admitted to any hospital within the 90-day intervention period
90 days

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
Number of days alive without delirium or coma in the ICU
Time Frame: Until ICU discharge, maximum 90 days
Number of days where patients are both alive and free of delirium and coma
Until ICU discharge, maximum 90 days
Number of patients with one or more serious adverse reactions to haloperidol and the total number of serious adverse reactions to haloperidol compared with placebo
Time Frame: Measured every day from inclusion until ICU discharge, maximum 90 days
Serious adverse reactions are: Anaphylactic reactions, Agranulocytosis, Pancytopenia, Ventricular arrhythmia, Extrapyramidal symptoms, Tardive dyskinesia, Malignant Neuroleptic Syndrome, Acute hepatic failure
Measured every day from inclusion until ICU discharge, maximum 90 days
Usage of escape medicine
Time Frame: Measured every day from inclusion until ICU discharge, maximum 90 days
Number of patients receiving escape medicine and number of days with escape medicine per patients
Measured every day from inclusion until ICU discharge, maximum 90 days
Number of days alive without mechanical ventilation within 90 days postrandomisation
Time Frame: Measured every day from inclusion until ICU discharge, maximum 90 days
Number of days where patients are both alive and free of mechanical ventilation
Measured every day from inclusion until ICU discharge, maximum 90 days
Mortality
Time Frame: 1 year
Landmark mortality 1 year post-randomisation
1 year
Quality of life (five level)
Time Frame: 1 year
EQ-5D-5L total score 1 year post-randomisation (1-5 of each of the five domains)
1 year
Quality of life (overall self assessment)
Time Frame: 1 year
EQ-Visual Analogue Scale 1 year post-randomisation (0-100)
1 year
Cognitive function 1 year after randomisation at selected sites
Time Frame: 1 year
Repeated Battery for the Assesment of Neuropsychological Status score 1 year post-randomisation at selected sites (40-150)
1 year
Executive function 1 year after randomisation at selected sites
Time Frame: 1 year
Trail Making Test 1 year post-randomisation at selected sites (40-150)
1 year
A health economic analysis
Time Frame: 90 days
The analytic details will be based on the primary results of the trial (cost-benefit or cost-minimisation analyses)
90 days
Cognitive function at admission
Time Frame: At inclusion (within the first week)
Informant Questionnaire on Cognitive Decline in the Elderly at ICU admission at selected sites (40-150)
At inclusion (within the first week)

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.
Zealand University Hospital

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.
Copenhagen Trial Unit, Center for Clinical Intervention Research
Scandinavian Critical Care Trials Group
Centre for Research in Intensive Care (CRIC)
The Danish Centre of Applied Social Science (VIVE)

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.
  • Study Chair: Jørn Wetterslev, MD, PhD, Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Study Chair: OIe Mathiesen, MD, PhD, Zealand University Hospital
  • Study Chair: Anders Perner, MD,PhD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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.
June 13, 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.
July 9, 2022

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.
July 1, 2023

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).
November 30, 2017

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.
December 30, 2017

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.
January 8, 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.
January 18, 2023

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.
January 12, 2023

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.
January 1, 2023

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.
  • REG-169-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: DOI: 10.1111/aas.13661
    Information comments: Published Statistical Analysis Plan for the AID-ICU trial
  2. Study Protocol
    Information identifier: DOI: 10.1111/aas.13453
    Information comments: Published Study Protocol for the AID-ICU trial

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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