Evaluation of a bundled intervention to restore circadian rhythm in critically ill sepsis patients- A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rhythmicity of serum melatonin
研究概览
简要总结
In this randomized controlled study, n=150 critically ill adult patients with a diagnosis of ‘sepsis’ as per Sepsis- 3 criterial will be recruited. Eligible patients will be randomized to either group B (bundled care to preserve circadian rhythm) and group S (standard of care). ‘Bundled care’ will included Zeitgeber optimization, protocolized pain control, low dose night time dexmedetomidine, postponing non- urgent care to daytime, minimization of night time light and sound exposure. All patients will be followed daily, for development of ICU acquired delirium, organ dysfunction and requirement of other organ support. Blood samples will be obtained four times daily (3.00 AM, 6.00 AM, 2.00 PM and 8.00 PM) for first two days of ICU stay (day 1, & 2) and similarly on day 6 and 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult (aged between 18 and 75y), critically ill, patients with a diagnosis of sepsis as per Sepsis- 3 criteria.
排除标准
- •Exclusion Criteria:
- •Refusal to participate
- •Pregnancy or post- partum up to 6 weeks
- •Patients with history of known psychiatric illness
- •Patients with known history of sleep disturbance.
结局指标
主要结局
Rhythmicity of serum melatonin
时间窗: At day 7 since randomisation
次要结局
- Secondary objectives will be as follows:(1. To compare serum IL-1, Il-2, IL-6, IL-10 at day 7 post- randomization)
研究者
Dr Souvik Maitra
All India Institute of Medical Sciences