Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
160 participants
INTERVENTIONAL
2025-02-01
2026-04-01
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Septic Shock Standard of Care (SOC)
Placebo suspension and capsules
Placebo suspension or capsule
Indistinguishable suspension or capsule
Septic shock Oral Bedtime Melatonin (OBM)
100 mg suspension or in capsules OBM
Oral Bedtime Melatonin
100 mg oral suspension or capsule given at bedtime
Resuscitated Cardiorespiratory Arrest SOC
Placebo suspension and capsules
Placebo suspension or capsule
Indistinguishable suspension or capsule
Resuscitated Cardiorespiratory Arrest OBM
100 mg suspension or in capsules OBM
Oral Bedtime Melatonin
100 mg oral suspension or capsule given at bedtime
Ischemic Stroke (SOC)
Placebo suspension and capsules
Placebo suspension or capsule
Indistinguishable suspension or capsule
Ischemic stroke (OBM)
100 mg suspension or in capsules OBM
Oral Bedtime Melatonin
100 mg oral suspension or capsule given at bedtime
Hemorraghic stroke (SOC)
Placebo suspension and capsules
Placebo suspension or capsule
Indistinguishable suspension or capsule
Hemorrhagic stroke (OBM)
100 mg suspension or in capsules OBM
Oral Bedtime Melatonin
100 mg oral suspension or capsule given at bedtime
Interventions
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Oral Bedtime Melatonin
100 mg oral suspension or capsule given at bedtime
Placebo suspension or capsule
Indistinguishable suspension or capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Hospital San Carlos, Madrid
OTHER
Responsible Party
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Miguel Sanchez Garcia
Director Critical Care Department
Other Identifiers
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Mel-ICU
Identifier Type: -
Identifier Source: org_study_id
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