Oral Bedtime Melatonin in Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Mortality at 90 days
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Indistinguishable oral suspension or capsule
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU stay >5 days
排除标准
- •ominous prognosis
研究组 & 干预措施
Septic shock Oral Bedtime Melatonin (OBM)
100 mg suspension or in capsules OBM
干预措施: Oral Bedtime Melatonin (Drug)
Septic Shock Standard of Care (SOC)
Placebo suspension and capsules
干预措施: Placebo suspension or capsule (Drug)
Resuscitated Cardiorespiratory Arrest SOC
Placebo suspension and capsules
干预措施: Placebo suspension or capsule (Drug)
Resuscitated Cardiorespiratory Arrest OBM
100 mg suspension or in capsules OBM
干预措施: Oral Bedtime Melatonin (Drug)
Ischemic Stroke (SOC)
Placebo suspension and capsules
干预措施: Placebo suspension or capsule (Drug)
Ischemic stroke (OBM)
100 mg suspension or in capsules OBM
干预措施: Oral Bedtime Melatonin (Drug)
Hemorraghic stroke (SOC)
Placebo suspension and capsules
干预措施: Placebo suspension or capsule (Drug)
Hemorrhagic stroke (OBM)
100 mg suspension or in capsules OBM
干预措施: Oral Bedtime Melatonin (Drug)
结局指标
主要结局
Mortality at 90 days
时间窗: Inclusion to 90 days
All-cause mortality
次要结局
未报告次要终点
研究者
Miguel Sanchez Garcia
Director Critical Care Department
Hospital San Carlos, Madrid