Status:
NOT_YET_RECRUITING
Oral Bedtime Melatonin in Critically Ill Patients
Lead Sponsor:
Hospital San Carlos, Madrid
Collaborating Sponsors:
Universidad Complutense de Madrid
Conditions:
Septic Shock
Stroke Hemorrhagic
Eligibility:
All Genders
Phase:
PHASE4
Brief 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. Mela...
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 su...
Eligibility Criteria
Inclusion
- ICU stay \>5 days
Exclusion
- ominous prognosis
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06156059
Start Date
February 1 2025
End Date
April 1 2026
Last Update
March 1 2024
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