Low-Dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Septic Patients in Intensive Care Unit: a Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Incidence of delirium within the first 7 days after enrollment
研究概览
简要总结
Delirium is common in septic patients, especially those receiving mechanical ventilation in the intensive care unit (ICU). Dexmedetomidine is a highly selective α2 adrenoreceptor agonist with anxiolytic, sedative, analgesic, and anti-inflammatory effects. Use of dexmedetomidine in mechanically ventilated ICU patients is associated with less delirium and improved outcomes. However, dexmedetomidine infusion produces dose-dependent bradycardia and hypotension; these limited the use of dexmedetomidine in ICU patients. This study is designed to test the hypothesis that low-dose dexmedetomidine infusion can also reduce delirium in mechanically ventilated ICU patients with sepsis.
详细描述
Delirium is an acutely occurred and fluctuating disorder of consciousness, attention, and cognition. The occurrence of delirium is associated with worse outcomes including prolonged mechanical ventilation, prolonged length of stay in ICU and hospital, increased complications, higher in-hospital mortality, and evaluated medical expenses. It is also associated with worse long-term outcomes including cognitive decline, worse quality of life, and shortened long-term survival.
Dexmedetomidine is a highly selective α2 adrenoreceptor agonist with anxiolytic, sedative, analgesic, and anti-inflammatory effects. Studies showed that use of dexmedetomidine is associated with less delirium in ICU patients. Potential mechanisms may include better sleep quality, less consumption of opioids and benzodiazepines, and suppressed inflammatory response.
The incidence of sepsis in ICU patients is as high as 47.2%; 93% of septic patients relying on mechanical ventilation. Delirium is common in septic patients; the reported incidences varies from 20% to 50%. The incidence of delirium in critically ill patients with mechanical ventilation is up to 60-84%. However, the majority of mechanically ventilated ICU patients are sedated with propofol; only 10% of them are given dexmedetomidine. A main reason is that dexmedetomidine infusion is associated with dose-related bradycardia and hypotension.
In a previous study, might-time low-dose dexmedetomidine infusion (0.1 μg/kg/h) improved subjective sleep quality and reduced delirium in elderly patients admitted to ICU after surgery. In another study of ICU patients receiving mechanical ventilation, low-dose dexmedetomidine infusion (0-0.5 μg/kg/h) based on protocol sedation also reduced delirium and shortened mechanical ventilation without increasing adverse events. We hypothesized that, in ICU septic patients with mechanical ventilation, low-dose dexmedetomidine infusion (0.1-0.2 μg/kg/h) might also reduce delirium.
The purpose of this study is to investigate the effect of low-dose dexmedetomidine infusion on incidence of delirium in ICU septic patients with mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older;
- •Admitted to the ICU;
- •With expected mechanical ventilation duration ≥12 hours;
- •Meet the diagnostic criteria of sepsis (sepsis 3.0; patient with infection and a sequential organ failure assessment score ≥2).
排除标准
- •Refuse to participate in;
- •History of schizophrenia, epilepsy, parkinsonism, or myasthenia gravis;
- •Inability to communicate (coma, profound dementia, or language barrier);
- •Brain injury or neurosurgery;
- •Left ventricular ejection fraction (LVEF) less than 30%, sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second degree or greater atrioventricular block without pacemaker;
- •Serious hepatic dysfunction (Child-Pugh class C);
- •Serious renal dysfunction (undergoing dialysis);
- •With expected survival for no more than 24 hours;
- •Allergic to dexmedetomidine;
- •Other conditions that were considered unsuitable for study participation.
研究组 & 干预措施
Dexmedetomidine group
Dexmedetomidine is infused at a rate of 0.1-0.2 ug/kg/h during mechanical ventilation, for a maximum of 7 days.
干预措施: Dexmedetomidine (Drug)
Placebo group
Placebo (normal saline) is infused at a same rate as in the dexmedetomidine group during mechanical ventilation, for a maximum of 7 days.
干预措施: Placebo (normal saline) (Drug)
结局指标
主要结局
Incidence of delirium within the first 7 days after enrollment
时间窗: Up to 7 days after enrollment
Delirium is assessed twice daily (from 06:00 to 10:00 and from 18:00 to 20:00) with the Confusion Assessment Method for the intensive care unit (CAM-ICU).
次要结局
- Length of stay in the ICU.(Up to 30 days after enrollment)
- Length of stay in the hospital.(Up to 30 days after enrollment)
- All-cause 30-day mortality(Up to 30 days after enrollment)
- Duration of mechanical ventilation.(Up to 30 days after enrollment)
- 30-day cognitive function(On the 30th day after enrollment.)
- Incidence of non-delirium complications.(Up to 30 days after enrollment)
- 30-day quality of life(On the 30th day after enrollment.)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital