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NCT06156059 Clinical Trial

Oral Bedtime Melatonin in Critically Ill Patients

Septic Shock Clinical Trial

— Mel-ICU  

Official title:
Oral Bedtime Melatonin in Critically Ill Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06156059
Other study ID # Mel-ICU
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date February 1, 2025
Est. completion date April 1, 2026

Study information
Verified date February 2024
Source Hospital San Carlos, Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 160
Est. completion date April 1, 2026
Est. primary completion date February 1, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - ICU stay >5 days Exclusion Criteria: - ominous prognosis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oral Bedtime Melatonin
100 mg oral suspension or capsule given at bedtime
• Placebo suspension or capsule
Indistinguishable suspension or capsule

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Hospital San Carlos, Madrid Universidad Complutense de Madrid

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality at 90 days All-cause mortality Inclusion to 90 days
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