ACTRN12616000436471已完成2 期
Pro-phylactic administration of Melatonin for the prevention of Delirium in Intensive Care units – a randomized placebo controlled trial (Pro-MEDIC study)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 850
研究概览
简要总结
The early use of melatonin did not result in reduced delirium in intensive care patients. We also did not see a change in the quality or duration of sleep or any of the other secondary outcomes between the patients who received melatonin and those who received placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients admitted to the Intensive Care Unit, identified by the treating intensivist as expected to have an ICU length of stay >72 hours. Patients must be enrolled within 48 hours of their ICU admission.
排除标准
- •1 Patients already on melatonin before their admission to ICU
- •2 Prior hypersensitivity reaction to any of the components of the study drug
- •3 Patients expected to be discharged within 72 hrs of their ICU admission
- •4 Non English speaking
- •5 Expected or inevitable death within next 48 hours
- •6 Patients that are not expected to improve adequately to be able to be assessed with a CAM-ICU score during their ICU stay
- •7 Patients that are not able to be assessed due to neurological problems that would affect their ability to participate in a CAM-ICU assessment (as judged by treating physician)
- •8 No enteral route – melatonin not available in intravenous formulation
- •9 Pregnancy or breastfeeding.
- •10. Hepatic impairment defined as Alanine Transferase (ALT) >500 IU/L, previous liver transplant or liver cirrhosis categories Childs-Pugh B and C.
研究者
相似试验
已完成
不适用
Can Melatonin prevent delirium in ICU patients or not ?CTRI/2021/10/037315All India Institute of Medical Sciences New Delhi50
尚未招募
4 期
Effect of tablet Melatonin on prevention of Confusion in severe COVID 19 patients admitted in ICCTRI/2021/12/038630Dr Suhasini Hubli
进行中（未招募）
1 期
Melatonin supplementation as an adjuvant therapy in neonatal respiratory distress syndromerespiratory distress syndromeneonatesrespiratorydistresssyndromeTCTR20200326001mohamed shawky elfarargy100
尚未招募
不适用
Effectiveness of Melatonin in managing sleep impairment in Opioid withdrawal patientsCTRI/2022/05/042865Sri Guru Ram Rai Institute of Medical and Health Sciences
终止
3 期
Prevention of Delirium in Inpatients Utilizing MelatoninDeliriumNCT02654314Yale University277