Delirium
Conditions
Keywords
ICU Delirium, Haloperidol
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.
Interventions
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.
OTHERSaline (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.
Sponsors
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)
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Mortality | 1 year | Landmark mortality 1 year post-randomisation |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
Countries
Denmark, Finland, Italy, United Kingdom
Outcome results
None listed