Treatment of delirium in critically ill adult patients in intensive care unit.
Conditions
Interventions
Trade Name: Serenase/haldol
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intravenous use
Sponsors
Zealand University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Acute admission to the ICU AND - Age = 18 years AND - Diagnosed delirium with a validated screening tool as either CAM-ICU or ICDSC. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800
Exclusion criteria
Exclusion criteria: - Contraindications to haloperidol - Habitual treatment with any antipsychotic medication - Permanently incompetent (e.g. dementia, mental retardation) - Delirium assessment non-applicable (coma or language barriers) - Withdrawal from active therapy or brain death - Fertile women (women < 50 years) 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 |
|---|---|
| Main Objective: To assess benefits and harms of haloperidol in adult, critically ill patients with delirium in the ICU. The primary objective is to determine, if haloperidol treatment in ICU patients with delirium will increase the number of days alive out of the hospital within 90 days. This primary objective includes 90 days mortality and length of hospital stay within 90 days after randomisation. ;Secondary Objective: To investigate if haloperidol as compared with placebo in ICU patients with delirium will change the: - Number of days alive without delirium or coma in the ICU - Number of patients with one or more adverse reactions and/or the total number of adverse reactions to haloperidol compared with placebo. - Number of patients needing one or more doses of escape medicine and or the dosages of escape medicine per patient in the haloperidol Group compared with the placebo group - Number of days alive without mechanical ventilation in the 90-day trial period - One-year mortality after inclusion - Measurement of cognitive function one year after inclusion on selected trial sites. - A health economic analysis will be performed. ;Primary end point(s): Days alive out of the hospital within 90 days post-randomisation;Timepoint(s) of evaluation of this end point: 90 days post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Endpoint number 1-4: 90 days post-randomisation Endpoint number 5-8: 1 year post-randomisation;Secondary end point(s): 1. Number of days alive without delirium and coma in the ICU 2. Number of patients with one or more serious adverse reactions to haloperidol and total number of serious adverse reactions to haloperidol 3. Number of patients needing one or more doses of escape medicines and number of days with escape medicines per patient 4. Number of days alive without mechanical ventilation in the 90-day period 5. 1-year mortality post-randomisation 6. EQ-5D-5L and EQ-VAS one year after randomisation. Patients who have died will be assigned the lowest possible EQ-5D-5L and EQ-VAS score. 7. Cognitive function 1-year after randomisation as assessed using RBANS score at selected sites. 8. A health economic analysis will be performed. The analytic details will be based on the result of the trial and specified (cost-effectiveness vs. cost-minimisation analyses). Outcomes will be one-year mortality and Quality adjusted Life Years (QALYs). The latter will be conducted on the basis of Eq-5D-5L. The inclusion of QALYs generates a cost-utility analysis. | — |
Countries
Denmark, Finland, Italy, Spain, United Kingdom
Contacts
Public ContactLone Musaeus Poulsen
Department of Anaesthesia and intensive Care Medicine, Zealand University Hospital, Koege
Outcome results
None listed