Agents Intervening Against Delirium in Intensive Care Unit
- Conditions
- Delirium
- Interventions
- Other: Saline (0,9%)
- Registration Number
- NCT03392376
- Lead Sponsor
- Zealand University Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Acute admission to the ICU AND
- Age ≥ 18 years AND
- Diagnosed delirium with validated screening Tool as either CAM-ICU or ICDSC
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Haloperidol injection Haloperidol Injection Haloperidol 2,5mg x 3 daily, with additional as needed doses to a maximum of 20mg/daily. Other name: Serenase Normal Saline Saline (0,9%) Saline (0,9%)
- Primary Outcome Measures
Name Time Method Days alive out of the hospital within 90 days post-randomization 90 days Number of days alive and out of hospital
90-day mortality 90 days Death from any cause within 90 days post-randomization
Hospital Length of Stay 90 days Total number of days the patient is admitted to any hospital within the 90-day intervention period
- Secondary Outcome Measures
Name Time Method Mortality 1 year Landmark mortality 1 year post-randomisation
Number of days alive without mechanical ventilation within 90 days postrandomisation Measured every day from inclusion until ICU discharge, maximum 90 days Number of days where patients are both alive and free of mechanical ventilation
Quality of life (five level) 1 year EQ-5D-5L total score 1 year post-randomisation (1-5 of each of the five domains)
Quality of life (overall self assessment) 1 year EQ-Visual Analogue Scale 1 year post-randomisation (0-100)
Cognitive function at admission At inclusion (within the first week) Informant Questionnaire on Cognitive Decline in the Elderly at ICU admission at selected sites (40-150)
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 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
Usage of escape medicine 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
Number of days alive without delirium or coma in the ICU Until ICU discharge, maximum 90 days Number of days where patients are both alive and free of delirium and coma
Executive function 1 year after randomisation at selected sites 1 year Trail Making Test 1 year post-randomisation at selected sites (40-150)
Cognitive function 1 year after randomisation at selected sites 1 year Repeated Battery for the Assesment of Neuropsychological Status score 1 year post-randomisation at selected sites (40-150)
A health economic analysis 90 days The analytic details will be based on the primary results of the trial (cost-benefit or cost-minimisation analyses)
Trial Locations
- Locations (16)
Dept. Intensive Care, Aabenraa Hospital
🇩🇰Aabenraa, Denmark
Dept. of Intensive Care, Aalborg University Hospital
🇩🇰Aalborg, Denmark
Dept. of Intensive Care, Sønderborg Hospital
🇩🇰Sønderborg, Denmark
Dept of intensive care, Odense University Hospital
🇩🇰Odense, Denmark
Dept. of Intensive Care, Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Dept. of Neurosurgical Intensive Care, San Gerardo Hospital, Monza.
🇮🇹Monza, Italy
UHW Adult Critical Care Cardiff
🇬🇧Cardiff, United Kingdom
Dept. of Intensive Care, Herlev Hospital
🇩🇰Herlev, Denmark
Dept. of Intensive Care, Herning Hospital
🇩🇰Herning, Denmark
Dept. of Intensive Care, Nordsjaelland Hospital
🇩🇰Hillerød, Denmark
Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
🇩🇰Copenhagen, 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, Zealand University Hospital Roskilde
🇩🇰Roskilde, Denmark