Oral Bedtime Melatonin in Critically Ill Patients (Mel-ICU)

February 28, 2024 updated by: Miguel Sanchez Garcia, Hospital San Carlos, Madrid

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ICU stay >5 days

Exclusion Criteria:

  • ominous prognosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at 90 days
Time Frame: Inclusion to 90 days
All-cause mortality
Inclusion to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Collaborators

Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

November 26, 2023

First Submitted That Met QC Criteria

November 26, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mel-ICU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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