Oral Bedtime Melatonin in Critically Ill Patients

Phase 4

Not yet recruiting

• Conditions: Septic Shock; Strokes Thrombotic; Cardiac Arrest; Stroke Hemorrhagic
• Interventions: Drug: Placebo suspension or capsule; Drug: Oral Bedtime Melatonin

• Registration Number: NCT06156059
• Lead Sponsor: Hospital San Carlos, Madrid

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

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 Timeline

• Study First Submitted: 2023-11-26
• Study First Submitted QC: 2023-11-26
• Study First Posted: 2023-12-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01
• Study Start: 2025-02-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• ICU stay >5 days

Exclusion Criteria

• ominous prognosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resuscitated Cardiorespiratory Arrest SOC	Placebo suspension or capsule	Placebo suspension and capsules
Septic shock Oral Bedtime Melatonin (OBM)	Oral Bedtime Melatonin	100 mg suspension or in capsules OBM
Ischemic Stroke (SOC)	Placebo suspension or capsule	Placebo suspension and capsules
Septic Shock Standard of Care (SOC)	Placebo suspension or capsule	Placebo suspension and capsules
Resuscitated Cardiorespiratory Arrest OBM	Oral Bedtime Melatonin	100 mg suspension or in capsules OBM
Hemorraghic stroke (SOC)	Placebo suspension or capsule	Placebo suspension and capsules
Ischemic stroke (OBM)	Oral Bedtime Melatonin	100 mg suspension or in capsules OBM
Hemorrhagic stroke (OBM)	Oral Bedtime Melatonin	100 mg suspension or in capsules OBM

Primary Outcome Measures

Name	Time	Method
Mortality at 90 days	Inclusion to 90 days	All-cause mortality