Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep-wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID study.
Study Goal
The researchers aimed to determine whether melatonin (4 mg once daily) is superior to placebo in reducing delirium duration and improving outcomes in critically ill patients with hypoactive delirium.
Results Summary
The study was designed to assess melatonin's impact on delirium duration, delirium-free days, mortality, ventilator days, ICU/hospital stay, and sleep quality, but results were not yet reported in the abstract.
Population
Critically ill patients with hypoactive delirium in the ICU.
Effective Dosage
4 mg once daily.
Duration
Not specified in the abstract.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
once daily oral administration of melatonin 4 mg | decrease | duration of delirium | critically ill patients | - | demonstrate superiority | #1 |
once daily oral administration of melatonin 4 mg | neutral | delirium-free days | critically ill patients | - | - | #2 |
once daily oral administration of melatonin 4 mg | neutral | death at 28 days after study inclusion | critically ill patients | - | - | #3 |
once daily oral administration of melatonin 4 mg | neutral | number of ventilator days | critically ill patients | - | - | #4 |
once daily oral administration of melatonin 4 mg | neutral | length of ICU stay | critically ill patients | - | - | #5 |
once daily oral administration of melatonin 4 mg | neutral | length of hospital stay | critically ill patients | - | - | #6 |
once daily oral administration of melatonin 4 mg | neutral | sleep quality | critically ill patients | - | - | #7 |
once daily oral administration of melatonin 4 mg | neutral | activities of daily living | critically ill patients | - | - | #8 |
once daily oral administration of melatonin 4 mg | neutral | mortality | critically ill patients | - | - | #9 |
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 ( 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.