Clinical trial NCT03392376: Agents Intervening Against Delirium in Intensive Care Unit
Official title: Agents Intervening Against Delirium in Intensive Care Unit (AID-ICU) A Randomized, Blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Delirium
Keywords: ICU Delirium
Haloperidol
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Centre for Research in Intensive Care (CRIC)
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Scandinavian Critical Care Trials Group
name: The Danish Centre of Applied Social Science (VIVE)
First posted: 2018-01-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Days alive out of the hospital within 90 days post-randomization
timeFrame: 90 days
measure: 90-day mortality
timeFrame: 90 days
measure: Hospital Length of Stay
timeFrame: 90 days
Secondary outcomes:
measure: Number of days alive without delirium or coma in the ICU
timeFrame: Until ICU discharge, maximum 90 days
measure: 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
timeFrame: Measured every day from inclusion until ICU discharge, maximum 90 days
measure: Usage of escape medicine
timeFrame: Measured every day from inclusion until ICU discharge, maximum 90 days
measure: Number of days alive without mechanical ventilation within 90 days postrandomisation
timeFrame: Measured every day from inclusion until ICU discharge, maximum 90 days
measure: Mortality
timeFrame: 1 year
measure: Quality of life (five level)
timeFrame: 1 year
measure: Quality of life (overall self assessment)
timeFrame: 1 year
measure: Cognitive function 1 year after randomisation at selected sites
timeFrame: 1 year
measure: Executive function 1 year after randomisation at selected sites
timeFrame: 1 year
measure: A health economic analysis
timeFrame: 90 days
measure: Cognitive function at admission
timeFrame: At inclusion (within the first week)
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Dept. Intensive Care, Aabenraa Hospital
city: Aalborg
country: Denmark
facility: Dept. of Intensive Care, Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
city: Herlev
country: Denmark
facility: Dept. of Intensive Care, Herlev Hospital
city: Herning
country: Denmark
facility: Dept. of Intensive Care, Herning Hospital
city: Hillerød
country: Denmark
facility: Dept. of Intensive Care, Nordsjaelland Hospital
city: Hjørring
country: Denmark
facility: Regionshospitalet Nordjylland, Hjørring
city: Holstebro
country: Denmark
facility: Dept. of Intensive Care, Holstebro Hospital
city: Køge
country: Denmark
facility: Dept. of Intensive Care, Zealand University Hospital, Køge
city: Nykøbing Falster
country: Denmark
facility: Dept. of Intensive Care, Nykøbing Falster Hospital
city: Odense
country: Denmark
facility: Dept of intensive care, Odense University Hospital
city: Roskilde
country: Denmark
facility: Dept. of Intensive Care, Zealand University Hospital Roskilde
city: Sønderborg
country: Denmark
facility: Dept. of Intensive Care, Sønderborg Hospital
city: Helsinki
country: Finland
facility: Dept. of Intensive Care, Helsinki University Central Hospital
city: Monza
country: Italy
facility: Dept. of Neurosurgical Intensive Care, San Gerardo Hospital, Monza.
city: Cardiff
country: United Kingdom
facility: UHW Adult Critical Care Cardiff
Study officials:
affiliation: Zealand University Hospital
name: OIe Mathiesen, MD, PhD
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Anders Perner, MD,PhD
role: STUDY_CHAIR
affiliation: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Jørn Wetterslev, MD, PhD
role: STUDY_CHAIR
References:
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.