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Oral Bedtime Melatonin in Critically Ill Patients

NCT06156059 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-03-01

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Oral Bedtime Melatonin

100 mg oral suspension or capsule given at bedtime

DRUG

Placebo suspension or capsule

Indistinguishable suspension or capsule

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    collaborator OTHER

  • Hospital San Carlos, Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-02-01
Completion
2026-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06156059 on ClinicalTrials.gov