Agents Intervening Against Delirium in Intensive Care Unit

Zealand University Hospital1,000 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,000

Conditions

Delirium

Interventions

Haloperidol InjectionDRUG

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.

Saline (0,9%)OTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (16)

Dept. Intensive Care, Aabenraa Hospital

Aabenraa, Denmark

Dept. of Intensive Care, Aalborg University Hospital

Aalborg, Denmark

Outcomes

Primary Outcomes

Days alive out of the hospital within 90 days post-randomization

Number of days alive and out of hospital

Time frame: 90 days

90-day mortality

Death from any cause within 90 days post-randomization

Time frame: 90 days

Hospital Length of Stay

Total number of days the patient is admitted to any hospital within the 90-day intervention period

Time frame: 90 days

Secondary Outcomes

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

Time frame: Until ICU discharge, maximum 90 days

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

Time frame: Measured every day from inclusion until ICU discharge, maximum 90 days

Usage of escape medicine

Number of patients receiving escape medicine and number of days with escape medicine per patients

Time frame: Measured every day from inclusion until ICU discharge, maximum 90 days

Number of days alive without mechanical ventilation within 90 days postrandomisation

Number of days where patients are both alive and free of mechanical ventilation

Data from ClinicalTrials.gov

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