Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change of resting energy expenditure compared to baseline at 33C°
研究概览
简要总结
The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.
详细描述
Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers are in use, together with analgesia and sedation, during the cooling process in many centers to prevent shivering. However, neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolonged ICU stay. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, the advantages and disadvantages of neuromuscular blockers during therapeutic hypothermia need to be re-evaluated.
Aim of this study is to investigate if continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoiding an increase in energy expenditure in patients during therapeutic hypothermia and rewarming after cardiac arrest (initial 72h).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin
排除标准
- •age < 18
- •cardiac arrest >6 hours before admittance at the hospital
- •patients with known or clinically apparent pregnancy
- •patients who reach our hospital with a body temperature below 35°C
- •patients with known allergic reactions against rocuronium
- •patients with a history of myasthenia gravis
- •patients with obvious intoxication
- •wards of the state/prisoners
- •patients with known epileptic disease
研究组 & 干预措施
Neuromuscular blocker group
Continuous application of neuromuscular blockers during therapeutic hypothermia.
Bolus application of placebo in case of shivering.
干预措施: Rocuronium (Drug)
Placebo group
Continuous application of placebo during therapeutic hypothermia.
Bolus application of neuromuscular blockers in case of shivering.
干预措施: Placebo (Drug)
结局指标
主要结局
Change of resting energy expenditure compared to baseline at 33C°
时间窗: initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h
resting energy expenditure will be assessed with indirect calorimetry at different measurement time points: 1. 12-24 h after initiation of mild hypothermia (33C°) 2. during warming up (at 34.5°C) 3. during warming up (at 36°C) 4. during warming up (at 36.5°C - 37.5°C) 5. normal Temperature, after 48 - 72 h after initiation of mild hypothermia
次要结局
- Change of substrate oxidation rate (protein, fat and glucose) compared to baseline at 33C°(initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h)
研究者
Ulrike Holzinger
MD, Assoc Prof
Medical University of Vienna