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Mel-ICU: Oral Bedtime Melatonin in Critically Ill Patients

Sponsor
Hospital San Carlos, Madrid (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06156059
Collaborator
Universidad Complutense de Madrid (Other)
160
Enrollment
8
Arms
26
Anticipated Duration (Months)

Study Details

Study Description

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.

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral Bedtime Melatonin
  • Drug: Placebo suspension or capsule
 Phase 4

Detailed Description

We intend to perform 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 perform 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

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
double blind randomizeddouble blind randomized
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Indistinguishable oral suspension or capsule
Primary Purpose:
Treatment
Official Title:
Oral Bedtime Melatonin in Critically Ill Patients
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Septic Shock Standard of Care (SOC)

Placebo suspension and capsules

Drug: Placebo suspension or capsule
Indistinguishable suspension or capsule
Other Names:
  • Placebo

    		•
    Active Comparator: Septic shock Oral Bedtime Melatonin (OBM)

    100 mg suspension or in capsules OBM

    Drug: Oral Bedtime Melatonin
    100 mg oral suspension or capsule given at bedtime
    Other Names:
  • Oral melatonin

    		•
    Placebo Comparator: Resuscitated Cardiorespiratory Arrest SOC

    Placebo suspension and capsules

    Drug: Placebo suspension or capsule
    Indistinguishable suspension or capsule
    Other Names:
  • Placebo

    		•
    Active Comparator: Resuscitated Cardiorespiratory Arrest OBM

    100 mg suspension or in capsules OBM

    Drug: Oral Bedtime Melatonin
    100 mg oral suspension or capsule given at bedtime
    Other Names:
  • Oral melatonin

    		•
    Placebo Comparator: Ischemic Stroke (SOC)

    Placebo suspension and capsules

    Drug: Placebo suspension or capsule
    Indistinguishable suspension or capsule
    Other Names:
  • Placebo

    		•
    Active Comparator: Ischemic stroke (OBM)

    100 mg suspension or in capsules OBM

    Drug: Oral Bedtime Melatonin
    100 mg oral suspension or capsule given at bedtime
    Other Names:
  • Oral melatonin

    		•
    Placebo Comparator: Hemorraghic stroke (SOC)

    Placebo suspension and capsules

    Drug: Placebo suspension or capsule
    Indistinguishable suspension or capsule
    Other Names:
  • Placebo

    		•
    Active Comparator: Hemorrhagic stroke (OBM)

    100 mg suspension or in capsules OBM

    Drug: Oral Bedtime Melatonin
    100 mg oral suspension or capsule given at bedtime
    Other Names:
  • Oral melatonin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mortality at 90 days [Inclusion to 90 days]

      All-cause mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ICU stay >5 days
    Exclusion Criteria:
    • ominous prognosis

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hospital San Carlos, Madrid
    • Universidad Complutense de Madrid

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Miguel Sanchez Garcia, Director Critical Care Department, Hospital San Carlos, Madrid
    ClinicalTrials.gov Identifier:
    NCT06156059
    Other Study ID Numbers:
    • Mel-ICU
    First Posted:
    Dec 5, 2023
    Last Update Posted:
    Dec 5, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke
    Hemorrhagic Stroke
    Thrombotic Stroke
    Melatonin

    Study Results

    No Results Posted as of Dec 5, 2023