The trial will involve 190 critically ill patients receiving either 4 mg of melatonin or a placebo to assess its effect on .
The study aims to determine if melatonin is superior to placebo in reducing the duration of hypoactive delirium in ICU patients.
Delirium duration will be measured in 8-hour shifts as the primary outcome.
Secondary outcomes include delirium-free days, mortality at 28 days, and various measures of ICU and hospital stay.
Patients will be followed up at 3 and 12 months for assessments of daily living activities and mortality.
Simplified
INTRODUCTION: Delirium is frequently observed in the intensive care unit (ICU) population, in particular. Until today, there is no evidence for any reliable pharmacological intervention to treat delirium. The Basel BOMP-AID (etterutcome withelatonin compared tolacebodministered to normalize sleep-wake cycle and treat hypoactiveCUelirium) randomised trial targets improvement of therapy in critically ill patients and will be conducted as a counterpart to the Basel ProDex Study (Study Protocol, BMJ Open, July 2017) on hyperactive and mixed delirium. The aim of the BOMP-AID trial is to assess the superiority of melatonin to placebo for the treatment of hypoactive delirium in the ICU. The study hypothesis is based on the assumption that melatonin administered at night restores a normal circadian rhythm, and that restoration of a normal circadian rhythm will cure delirium. B O M P A I D
METHODS AND ANALYSIS: The Basel BOMP-AID study is an investigator-initiated, single-centre, randomised controlled clinical trial for the treatment of hypoactive delirium with the once daily oral administration of melatonin 4 mg versus placebo in 190 critically ill patients. The primary outcome measure is delirium duration in 8-hour shifts. Secondary outcome measures include delirium-free days and death at 28 days after study inclusion, number of ventilator days, length of ICU and hospital stay, and sleep quality. Patients will be followed after 3 and 12 months for activities of daily living and mortality assessment. Sample size was calculated to demonstrate superiority of melatonin compared with placebo regarding the duration of delirium. Results will be presented using an intention-to-treat approach.
ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of Northwestern and Central Switzerland and will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use; Good Clinical Practice (GCP) or ISO EN 14155 (as far as applicable), as well as all national legal and regulatory requirements. Study results will be presented in international conferences and published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: NCT03438526.
PROTOCOL VERSION: Clinical Study Protocol Version 3, 10.03.2019.
Key numbers
190 patients
Sample Size
Total number of patients planned for the trial.
Delirium duration in number of 8-hour shifts
Primary Outcome Measure
Measured in shifts to quantify delirium duration.
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