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Oral Bedtime Melatonin in Critically Ill Patients — Mel-ICU  

Septic Shock Clinical Trial

Official title:
Oral Bedtime Melatonin in Critically Ill Patients

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06156059
Study type Interventional
Source Hospital San Carlos, Madrid
Contact
Status Not yet recruiting
Phase Phase 4
Start date February 1, 2025
Completion date April 1, 2026
View Details
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