NCT06156059

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

November 26, 2023

Last Update Submit

February 28, 2024

Conditions

Septic ShockStroke HemorrhagicStrokes ThromboticCardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Mortality at 90 days

    All-cause mortality

    Inclusion to 90 days

Study Arms (8)

Septic Shock Standard of Care (SOC)

PLACEBO COMPARATOR

Placebo suspension and capsules

Drug: Placebo suspension or capsule

Septic shock Oral Bedtime Melatonin (OBM)

ACTIVE COMPARATOR

100 mg suspension or in capsules OBM

Drug: Oral Bedtime Melatonin

Resuscitated Cardiorespiratory Arrest SOC

PLACEBO COMPARATOR

Placebo suspension and capsules

Drug: Placebo suspension or capsule

Resuscitated Cardiorespiratory Arrest OBM

ACTIVE COMPARATOR

100 mg suspension or in capsules OBM

Drug: Oral Bedtime Melatonin

Ischemic Stroke (SOC)

PLACEBO COMPARATOR

Placebo suspension and capsules

Drug: Placebo suspension or capsule

Ischemic stroke (OBM)

ACTIVE COMPARATOR

100 mg suspension or in capsules OBM

Drug: Oral Bedtime Melatonin

Hemorraghic stroke (SOC)

PLACEBO COMPARATOR

Placebo suspension and capsules

Drug: Placebo suspension or capsule

Hemorrhagic stroke (OBM)

ACTIVE COMPARATOR

100 mg suspension or in capsules OBM

Drug: Oral Bedtime Melatonin

Interventions

Oral Bedtime MelatoninDRUG

100 mg oral suspension or capsule given at bedtime

Also known as: Oral melatonin
Hemorrhagic stroke (OBM)Ischemic stroke (OBM)Resuscitated Cardiorespiratory Arrest OBMSeptic shock Oral Bedtime Melatonin (OBM)
Placebo suspension or capsuleDRUG

Indistinguishable suspension or capsule

Also known as: Placebo
Hemorraghic stroke (SOC)Ischemic Stroke (SOC)Resuscitated Cardiorespiratory Arrest SOCSeptic Shock Standard of Care (SOC)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ICU stay \>5 days

You may not qualify if:

  • ominous prognosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shock, SepticHemorrhagic StrokeThrombotic StrokeHeart Arrest

Interventions

MelatoninCapsules

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIschemic StrokeHeart Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Indistinguishable oral suspension or capsule
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: double blind randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Critical Care Department

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 5, 2023

Study Start

February 1, 2025

Primary Completion

February 1, 2026

Study Completion

April 1, 2026

Last Updated

March 1, 2024

Record last verified: 2024-02