San Carlos Hospital, Madrid
Miguel Sanchez Garcia
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
Septic Shock
Stroke Hemorrhagic
Strokes Thrombotic
Cardiac Arrest
Oral Bedtime Melatonin
Placebo suspension or capsule
PHASE4
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 |
| Estimated Enrollment : | 160 participants |
| Masking : | QUADRUPLE |
| Masking Description : | Indistinguishable oral suspension or capsule |
| Primary Purpose : | TREATMENT |
| Official Title : | Oral Bedtime Melatonin in Critically Ill Patients |
| Actual Study Start Date : | 2025-02-01 |
| Estimated Primary Completion Date : | 2026-02-01 |
| Estimated Study Completion Date : | 2026-04-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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