search
Back to results

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

Primary Purpose

Delirium

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Haloperidol Injection
Saline (0,9%)
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring ICU Delirium, Haloperidol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dept. Intensive Care, Aabenraa Hospital
  • Dept. of Intensive Care, Aalborg University Hospital
  • Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
  • Dept. of Intensive Care, Herlev Hospital
  • Dept. of Intensive Care, Herning Hospital
  • Dept. of Intensive Care, Nordsjaelland Hospital
  • Regionshospitalet Nordjylland, Hjørring
  • Dept. of Intensive Care, Holstebro Hospital
  • Dept. of Intensive Care, Zealand University Hospital, Køge
  • Dept. of Intensive Care, Nykøbing Falster Hospital
  • Dept of intensive care, Odense University Hospital
  • Dept. of Intensive Care, Zealand University Hospital Roskilde
  • Dept. of Intensive Care, Sønderborg Hospital
  • Dept. of Intensive Care, Helsinki University Central Hospital
  • Dept. of Neurosurgical Intensive Care, San Gerardo Hospital, Monza.
  • UHW Adult Critical Care Cardiff

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Haloperidol injection

Normal Saline

Arm Description

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

Saline (0,9%)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 30, 2017
Last Updated
January 12, 2023
Sponsor
Zealand University Hospital
Collaborators
Centre for Research in Intensive Care (CRIC), Copenhagen Trial Unit, Center for Clinical Intervention Research, Scandinavian Critical Care Trials Group, The Danish Centre of Applied Social Science (VIVE)
search

1. Study Identification

Unique Protocol Identification Number
NCT03392376
Brief Title
Agents Intervening Against Delirium in Intensive Care Unit
Acronym
AID-ICU
Official Title
Agents Intervening Against Delirium in Intensive Care Unit (AID-ICU) A Randomized, Blinded, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
July 9, 2022 (Actual)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
Collaborators
Centre for Research in Intensive Care (CRIC), Copenhagen Trial Unit, Center for Clinical Intervention Research, Scandinavian Critical Care Trials Group, The Danish Centre of Applied Social Science (VIVE)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
ICU Delirium, Haloperidol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Haloperidol injection
Arm Type
Experimental
Arm Description
Haloperidol 2,5mg x 3 daily, with additional as needed doses to a maximum of 20mg/daily. Other name: Serenase
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Saline (0,9%)
Intervention Type
Drug
Intervention Name(s)
Haloperidol Injection
Other Intervention Name(s)
Serenase
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline (0,9%)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days alive out of the hospital within 90 days post-randomization
Description
Number of days alive and out of hospital
Time Frame
90 days
Title
90-day mortality
Description
Death from any cause within 90 days post-randomization
Time Frame
90 days
Title
Hospital Length of Stay
Description
Total number of days the patient is admitted to any hospital within the 90-day intervention period
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Number of days alive without delirium or coma in the ICU
Description
Number of days where patients are both alive and free of delirium and coma
Time Frame
Until ICU discharge, maximum 90 days
Title
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
Description
Serious adverse reactions are: Anaphylactic reactions, Agranulocytosis, Pancytopenia, Ventricular arrhythmia, Extrapyramidal symptoms, Tardive dyskinesia, Malignant Neuroleptic Syndrome, Acute hepatic failure
Time Frame
Measured every day from inclusion until ICU discharge, maximum 90 days
Title
Usage of escape medicine
Description
Number of patients receiving escape medicine and number of days with escape medicine per patients
Time Frame
Measured every day from inclusion until ICU discharge, maximum 90 days
Title
Number of days alive without mechanical ventilation within 90 days postrandomisation
Description
Number of days where patients are both alive and free of mechanical ventilation
Time Frame
Measured every day from inclusion until ICU discharge, maximum 90 days
Title
Mortality
Description
Landmark mortality 1 year post-randomisation
Time Frame
1 year
Title
Quality of life (five level)
Description
EQ-5D-5L total score 1 year post-randomisation (1-5 of each of the five domains)
Time Frame
1 year
Title
Quality of life (overall self assessment)
Description
EQ-Visual Analogue Scale 1 year post-randomisation (0-100)
Time Frame
1 year
Title
Cognitive function 1 year after randomisation at selected sites
Description
Repeated Battery for the Assesment of Neuropsychological Status score 1 year post-randomisation at selected sites (40-150)
Time Frame
1 year
Title
Executive function 1 year after randomisation at selected sites
Description
Trail Making Test 1 year post-randomisation at selected sites (40-150)
Time Frame
1 year
Title
A health economic analysis
Description
The analytic details will be based on the primary results of the trial (cost-benefit or cost-minimisation analyses)
Time Frame
90 days
Title
Cognitive function at admission
Description
Informant Questionnaire on Cognitive Decline in the Elderly at ICU admission at selected sites (40-150)
Time Frame
At inclusion (within the first week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OIe Mathiesen, MD, PhD
Organizational Affiliation
Zealand University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anders Perner, MD,PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jørn Wetterslev, MD, PhD
Organizational Affiliation
Copenhagen Trial Unit, Center for Clinical Intervention Research
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. Intensive Care, Aabenraa Hospital
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Facility Name
Dept. of Intensive Care, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Dept. of Intensive Care, Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Dept. of Intensive Care, Herning Hospital
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Dept. of Intensive Care, Nordsjaelland Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Regionshospitalet Nordjylland, Hjørring
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
Facility Name
Dept. of Intensive Care, Holstebro Hospital
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Facility Name
Dept. of Intensive Care, Zealand University Hospital, Køge
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Dept. of Intensive Care, Nykøbing Falster Hospital
City
Nykøbing Falster
ZIP/Postal Code
4800
Country
Denmark
Facility Name
Dept of intensive care, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Dept. of Intensive Care, Zealand University Hospital Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Dept. of Intensive Care, Sønderborg Hospital
City
Sønderborg
ZIP/Postal Code
6400
Country
Denmark
Facility Name
Dept. of Intensive Care, Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00120
Country
Finland
Facility Name
Dept. of Neurosurgical Intensive Care, San Gerardo Hospital, Monza.
City
Monza
Country
Italy
Facility Name
UHW Adult Critical Care Cardiff
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36286254
Citation
Andersen-Ranberg NC, Poulsen LM, Perner A, Wetterslev J, Estrup S, Hastbacka J, Morgan M, Citerio G, Caballero J, Lange T, Kjaer MN, Ebdrup BH, Engstrom J, Olsen MH, Oxenboll Collet M, Mortensen CB, Weber SO, Andreasen AS, Bestle MH, Uslu B, Scharling Pedersen H, Gramstrup Nielsen L, Toft Boesen HC, Jensen JV, Nebrich L, La Cour K, Laigaard J, Haurum C, Olesen MW, Overgaard-Steensen C, Westergaard B, Brand B, Kingo Vesterlund G, Thornberg Kyhnauv P, Mikkelsen VS, Hyttel-Sorensen S, de Haas I, Aagaard SR, Nielsen LO, Eriksen AS, Rasmussen BS, Brix H, Hildebrandt T, Schonemann-Lund M, Fjeldsoe-Nielsen H, Kuivalainen AM, Mathiesen O; AID-ICU Trial Group. Haloperidol for the Treatment of Delirium in ICU Patients. N Engl J Med. 2022 Dec 29;387(26):2425-2435. doi: 10.1056/NEJMoa2211868. Epub 2022 Oct 26.
Results Reference
derived
Links:
URL
http://www.cric.nu/aid-icu/
Description
LINK to the AID-ICU webpage

Learn more about this trial

Agents Intervening Against Delirium in Intensive Care Unit

We'll reach out to this number within 24 hrs