NCT06156059

Oral Bedtime Melatonin in Critically Ill Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Oxidative stress is one of the main mechanisms causing harm in severe infection with septic shock, ischemia-reperfusion injury in resuscitated cardiac arrest and ischemic and hemorrhagic stroke. Melatonin is a potent scavenger of the mediators of oxidative stress, oxygen and nitrogen-reactive species, which directly injure cell structures like walls and DNA and thus cause organ dysfunction. In a previous study we have observed that high-dose oral bedtime melatonin (OBM) is associated with improved organ function in severe Covid-19 patients

Detailed description

This is a double-blind randomized, adaptive trial in the 4 indications mentioned above giving 100 mg of OBM or placebo. Interim analyses with pre-specified stopping rules will be performed in each sub-study for specific outcome variables collected at scheduled timelines. Comparative organ dysfunction score (Sequential Organ Failure Evaluation-SOFA) will be done at baseline, 7, 14, and 30 days and mortality evaluated at 30 and 90 days. For the 3 study groups enrolling stroke and resuscitated cardiac arrest patients, the modified Rankin score and the CVC (Glasgow) at 30 and 90 days will be compared.

Conditions

• Septic Shock
• Stroke Hemorrhagic
• Strokes Thrombotic
• Cardiac Arrest

Interventions

Type	Name	Description
DRUG	Oral Bedtime Melatonin	100 mg oral suspension or capsule given at bedtime
DRUG	Placebo suspension or capsule	Indistinguishable suspension or capsule

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-02-01
• Completion: 2026-04-01
• First posted: 2023-12-05
• Last updated: 2024-03-01