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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
Melatonin versus placebo for improving sleep and treating low-activity delirium in ICU patients: a planned clinical trial
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Abstract
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.
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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.