"Haloperidol for Delirium in Intensive Care Unit Patients".
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The New England Journal of Medicine. Year Published. Volume(Issue):pages. PubMed•Full text•PDF
Contents
1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcomes 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
Does the use of haloperidol lead to a greater number of days alive and out of the hospital at 90 days compared to placebo in ICU patients with delirium?
The use of haloperidol in ICU patients with delirium did not result in a significantly greater number of days alive and out of the hospital at 90 days compared to placebo.
Haloperidol, a typical antipsychotic compound, is often used to treat delirium in ICU patients despite limited evidence supporting its effect. The Agents Intervening against Delirium in Intensive Care Unit (AID-ICU) multicenter, blinded, placebo-controlled trial found no significant difference in the number of days alive and out of the hospital at 90 days when comparing haloperidol and placebo treatment in ICU patients with delirium.
Currently, the use of haloperidol is not supported by clinical practice guidelines as evidence of its effect on delirium in ICU patients is limited.
- Multicenter, blinded, parallel-group, randomized, placebo-controlled trial. - N=1,000 patients with acute ICU admission and delirium. - Haloperidol vs. placebo. - Enrollment: June 14, 2018 - April 9, 2022. - Mean follow-up: 90 days after randomization. - Analysis: Intention-to-treat. - Primary outcome: Number of days alive and out of the hospital at 90 days after randomization.
Inclusion Criteria: Adult patients 18 years or older admitted to ICU for an acute condition with delirium diagnosed by CAM-ICU or ICDSC. Exclusion Criteria: Patients ineligible based on CAM-ICU or ICDSC criteria. Baseline Characteristics: Balanced between the two groups; included both hypoactive and hyperactive delirium patients.
Patients received either intravenous haloperidol (2.5 mg 3 times daily plus as-needed doses up to 20 mg) or placebo. Treatment was administered in the ICU for as long as delirium continued and as needed for recurrences.
Primary Outcomes: The mean number of days alive and out of the hospital at 90 days was 35.8 in the haloperidol group and 32.9 in the placebo group (P=0.22). Mortality at 90 days was 36.3% in the haloperidol group and 43.3% in the placebo group. Secondary Outcomes: Number of days alive without delirium or coma in the ICU, number of days alive without mechanical ventilation, the number of patients with serious adverse reactions, number of patients receiving rescue medication, and days with rescue medication per patient.
Low number of international sites and potential selection bias in screening may limit generalizability. The composite nature of the primary outcome and lack of detailed data on coexisting conditions and sedative use are limitations for interpretation of the trial results.
The trial was supported by grants from Innovation Fund Denmark, the Regional Medicines Fund, Zealand Region Research Fund, Intensive Care Symposium Hindsgavl, and the Foghts Foundation.
Full trial details and additional data are available in The New England Journal of Medicine, published on October 26, 2022, and updated on December 29, 2022.