Agents Intervening Against Delirium in Intensive Care Unit

Delirium Clinical Trial

— AID-ICU  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03392376
• Other study ID #: REG-169-2017
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 13, 2018
• Est. completion date: July 2023

Study information

• Verified date: January 2023
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: July 2023
• Est. primary completion date: July 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Delirium

Intervention

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:
• 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.

Locations

Country	Name	City	State
Denmark	Dept. Intensive Care, Aabenraa Hospital	Aabenraa
Denmark	Dept. of Intensive Care, Aalborg University Hospital	Aalborg
Denmark	Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet	Copenhagen
Denmark	Dept. of Intensive Care, Herlev Hospital	Herlev
Denmark	Dept. of Intensive Care, Herning Hospital	Herning
Denmark	Dept. of Intensive Care, Nordsjaelland Hospital	Hillerød
Denmark	Regionshospitalet Nordjylland, Hjørring	Hjørring
Denmark	Dept. of Intensive Care, Holstebro Hospital	Holstebro
Denmark	Dept. of Intensive Care, Zealand University Hospital, Køge	Køge
Denmark	Dept. of Intensive Care, Nykøbing Falster Hospital	Nykøbing Falster
Denmark	Dept of intensive care, Odense University Hospital	Odense
Denmark	Dept. of Intensive Care, Zealand University Hospital Roskilde	Roskilde
Denmark	Dept. of Intensive Care, Sønderborg Hospital	Sønderborg
Finland	Dept. of Intensive Care, Helsinki University Central Hospital	Helsinki
Italy	Dept. of Neurosurgical Intensive Care, San Gerardo Hospital, Monza.	Monza
United Kingdom	UHW Adult Critical Care Cardiff	Cardiff

Sponsors (5)

Lead Sponsor	Collaborator
Zealand University Hospital	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)

Countries where clinical trial is conducted

Denmark,  Finland,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days alive out of the hospital within 90 days post-randomization	Number of days alive and out of hospital	90 days
Primary	90-day mortality	Death from any cause within 90 days post-randomization	90 days
Primary	Hospital Length of Stay	Total number of days the patient is admitted to any hospital within the 90-day intervention period	90 days
Secondary	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	Until ICU discharge, maximum 90 days
Secondary	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	Measured every day from inclusion until ICU discharge, maximum 90 days
Secondary	Usage of escape medicine	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
Secondary	Number of days alive without mechanical ventilation within 90 days postrandomisation	Number of days where patients are both alive and free of mechanical ventilation	Measured every day from inclusion until ICU discharge, maximum 90 days
Secondary	Mortality	Landmark mortality 1 year post-randomisation	1 year
Secondary	Quality of life (five level)	EQ-5D-5L total score 1 year post-randomisation (1-5 of each of the five domains)	1 year
Secondary	Quality of life (overall self assessment)	EQ-Visual Analogue Scale 1 year post-randomisation (0-100)	1 year
Secondary	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)	1 year
Secondary	Executive function 1 year after randomisation at selected sites	Trail Making Test 1 year post-randomisation at selected sites (40-150)	1 year
Secondary	A health economic analysis	The analytic details will be based on the primary results of the trial (cost-benefit or cost-minimisation analyses)	90 days
Secondary	Cognitive function at admission	Informant Questionnaire on Cognitive Decline in the Elderly at ICU admission at selected sites (40-150)	At inclusion (within the first week)

External Links

•   LINK to the AID-ICU webpage