Dexmedetomidine After Cardiac Surgery for Prevention of Delirium: The Exactum Study a Randomised Double Blind Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 9
- 主要终点
- Delirium
研究概览
简要总结
We designed a prospective, double blind, randomized, controlled versus placebo study to evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and lower delirium in a population of post cardiac surgery patients. This population is characterized by longer ICU stay, more physical restraints such as catheters and drains, pain and sleep deprivation. It is associated with higher prevalence of Delirium and agitation leading to exposure to severe agitation related adverse events.
详细描述
Delirium occurs in about 25% of patients after cardiac surgery. It is an independent factor of poor outcome and recovery after ICU stay as it is associated with mortality and impaired mental function one year after its onset. It is associated with increased public health costs during the hospital stay and after.
The use of Dexmedetomidine as sedative medication is more and more described. It is well established that it can lower delirium onset comparatively to Midazolam or Propofol. It is also useful in agitated delirium as a complementary medication to reduce delirium duration. A study published by Su et al in 2016 assessed the efficacy of Dexmedetomidine in prevention of post-surgical delirium for patients older than 65 years after non cardiac surgery. Patients were mainly admitted in the ICU after abdominal surgery for malignant tumor. Dexmedetomidine was used at very low dose to promote sleep during ICU stay. In this study the onset of delirium was significantly lowered by one half for the first week after surgery. However, this study only focused on older patients and non-cardiac surgery population with short mechanical ventilation duration, short ICU stay and low incidence of complications.
We designed a prospective, double blind, randomized, controlled versus placebo study to evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and lower delirium in a population of post cardiac surgery patients. This population is characterized by longer ICU stay, more physical restraints such as catheters and drains, pain and sleep deprivation. It is associated with higher prevalence of Delirium and agitation leading to exposure to severe agitation related adverse events. In the study by Su and al low dose Dexmedetomidine did not induce adverse events such as bradycardia or hypotension, conversely safety outcomes showed that Dexmedetomidine use was associated with fewer tachycardia and hypoxaemia. Moreover, data shows that Dexmedetomidine is likely to play a cardio protective role in the same way as Clonidine. Those findings are encouraging for its use after cardiac surgery.
Delirium will be assessed by the Confusion Assessment Method for the ICU (CAM ICU) and the primary endpoint of the study is the occurrence of delirium in the first 7 days following surgery.
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)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 65 or more who undergo cardiac surgery on and off-pump: coronary artery bypass graft, cardiac valve replacement or both.
- •Consent signed
排除标准
- •history of mental illness, dementia
- •inclusion in another study evaluating sedation or pain
- •length of stay in ICU less than 24 hours
- •alpha 2 agonists allergy
- •surgery performed in an immediate emergency situation
- •uncontrolled hypotension
- •second and third degree atrioventricular block without pacemaker
- •severe hepatic insufficiency
- •acute cerebrovascular diseases
- •patient treated with clonidine
- •patient with disturbed preoperative liver assessment (hepatocellular insufficiency)
- •patient under guardianship or curatorship
研究组 & 干预措施
Dexmédétomidine
Intravenous infusion with electric syringe of Dexmedetomidine 0,4ug/ml. Rate 0,1ug/kg/h to 1,4ug/kg/h. Nightly infusion from 20:00 to 08:00. The drug is titrated to achieve RASS between -1 and 1. Modification of infusion rate by 0,1ug/kg/h is recommended with stabilization phase of 1 hour before another rate adjustment.
干预措施: Dexmedetomidine (Drug)
Sodium Chloride 0,9%
Intravenous infusion with electric syringe of normal saline. Rate modifications follow the same rules as in experimental group.
干预措施: Sodium chloride 0.9% (Drug)
结局指标
主要结局
Delirium
时间窗: 7 days
Occurrence of delirium diagnosed by the Confusion Assessment Method (CAM ICU) at any time in the first seven days after surgery
次要结局
- length of hospital stay(28 days)
- quality of life 3 months after surgery with the The Short Form (36) Health Survey score(90 days)
- cognitive capacity 3 months after surgery evaluated with the Cognitive Failures Questionnnaire (CFQ)(90 days)
- agitation related adverse events onset and number(7 days)
- Cognitive capacity(3 months)
- Intra hospital mortality and Mortality at 3 months of surgery(3 months)
- Self-assessment of sleep quality(7 days)
- Post-traumatic stress disorder(3 months)
- agitation with be assessed using the Richmond agitation and sedation score(7 days)
- length of ICU stay(28 days)