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

San Carlos Clinical Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Strokes Thrombotic; Stroke Hemorrhagic; Cardiac Arrest; Septic Shock

Treatments: Drug: Placebo suspension or capsule; Drug: Oral Bedtime Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT06156059

Mel-ICU

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• ICU stay >5 days

Exclusion criteria

• ominous prognosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

160 participants in 8 patient groups, including a placebo group

Septic Shock Standard of Care (SOC)

Placebo Comparator group

Description:

Placebo suspension and capsules

Treatment:

Drug: Placebo suspension or capsule

Septic shock Oral Bedtime Melatonin (OBM)

Active Comparator group

Description:

100 mg suspension or in capsules OBM

Treatment:

Drug: Oral Bedtime Melatonin

Resuscitated Cardiorespiratory Arrest SOC

Placebo Comparator group

Description:

Placebo suspension and capsules

Treatment:

Drug: Placebo suspension or capsule

Resuscitated Cardiorespiratory Arrest OBM

Active Comparator group

Description:

100 mg suspension or in capsules OBM

Treatment:

Drug: Oral Bedtime Melatonin

Ischemic Stroke (SOC)

Placebo Comparator group

Description:

Placebo suspension and capsules

Treatment:

Drug: Placebo suspension or capsule

Ischemic stroke (OBM)

Active Comparator group

Description:

100 mg suspension or in capsules OBM

Treatment:

Drug: Oral Bedtime Melatonin

Hemorraghic stroke (SOC)

Placebo Comparator group

Description:

Placebo suspension and capsules

Treatment:

Drug: Placebo suspension or capsule

Hemorrhagic stroke (OBM)

Active Comparator group

Description:

100 mg suspension or in capsules OBM

Treatment:

Drug: Oral Bedtime Melatonin