Prophylactic Melatonin for Delirium in Intensive Care (Pro-MEDIC): study protocol for a randomised controlled trial

Area of Science:

• Intensive care medicine
• Neuroscience
• Pharmacology

Background:

• Delirium is a common, serious complication in intensive care units (ICUs).
• It is linked to increased patient morbidity and mortality.
• Sleep disturbances and circadian rhythm disruption are implicated in delirium development.

Purpose of the Study:

• To determine if prophylactic melatonin administration reduces delirium rates in critically ill adults compared to placebo.
• To evaluate the impact of melatonin on sleep quality and other patient outcomes in the ICU.

Main Methods:

• Multi-center, randomized, placebo-controlled trial in Australian ICUs.
• 850 adult patients with expected ICU length of stay ≥72 hours enrolled.
• Patients received melatonin 4mg or placebo daily; delirium assessed using Confusion Assessment Method for the ICU score.

Main Results:

• Data on delirium prevalence, duration, severity, sleep quality, and patient outcomes were collected.
• A subgroup of 100 patients underwent polysomnography to assess sleep quality.

Conclusions:

• This trial represents the largest evaluation of melatonin for delirium prevention in critically ill patients.
• Results will inform clinical practice regarding melatonin use in ICUs.