跳至主要内容
临床试验/NCT02260258
NCT02260258已完成2 期

Neuromuscular Blockade for Post-Cardiac Arrest Care

Beth Israel Deaconess Medical Center5 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
83
试验地点
5
主要终点
Change in Lactate Over 24 Hours: Effect Estimate

研究概览

简要总结

The main purpose of this study is to evaluate if neuromuscular blockade improves lactate clearance (and preliminary secondary clinical outcome measures) as compared to usual care in post-cardiac arrest patients undergoing targeted temperature management.

详细描述

Out-of-hospital cardiac arrest (OHCA) occurs in more than 300,000 patients in the United States each year with an estimated mortality of greater than 90%. Unfortunately, we currently have little to offer in terms of treatment other than supportive care for the post-cardiac arrest patient. Neuromuscular blockade (NMB) is sometimes utilized in post-arrest patients particularly for the prevention of shivering. However, usage of NMB remains controversial and current American Heart Association (AHA) recommendations are to minimize utilization. Recent prospective randomized trials in patients with acute respiratory distress syndrome suggest a mortality benefit from NMB and an excellent safety profile. Furthermore, observational trials in both sepsis and post-cardiac arrest show that the use of NMB is associated with improved survival. Given this, we hypothesize that continuous NMB will be beneficial in post-arrest patients. In order to test this hypothesis, we propose a multi-center, randomized, open-label, phase II trial in post-CA patients comparing sustained NMB administration for 24 hours to standard of care after return of spontaenous circulation (ROSC). We will enroll adult, comatose OHCA patients with ROSC and will utilize an already existing clinical trials network for the completion of the study. Patients will be randomized to receive either rocuronium for 24 hours or to receive placebo with usual care. Previous data from our group has suggested that lactate levels in the post-arrest patient are a good surrogate marker for mortality. We have therefore chosen to utilize lactate levels at 24 hours as the primary endpoint for the current trial. Secondarily we will evaluate clinical endpoints including length of stay (LOS), in-hospital mortality, and good neurological outcome. We will perform a sub-study of inflammatory markers and oxygen consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (≥ 18 years)
  • Cardiac arrest with sustained return of spontaneous circulation (ROSC)
  • Comatose (i.e., not following commands) following ROSC
  • Undergoing targeted temperature management (TTM)
  • Time of enrollment ≤ 6 hours from initiation of targeted temperature management
  • Serum Lactate ≥2

排除标准

  • Pre-existing dementia, severe brain injury, or dependence on others for activities of daily living (i.e. a modified Rankin scale (mRS) score of 4 or higher)
  • Traumatic etiology of the cardiac arrest
  • Protected population (pregnant, prisoner)

研究组 & 干预措施

Rocuronium

Experimental

Patients will receive a bolus dose of 1 mg/kg, then a continuous intravenous (IV) infusion as per standard intensive care unit practice.

Of note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).

干预措施: Rocuronium (Drug)

Usual Care

Placebo Comparator

Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.

干预措施: Normal Saline (Drug)

结局指标

主要结局

Change in Lactate Over 24 Hours: Effect Estimate

时间窗: 24 hours

Interaction between allocated treatment and time: ratio of geometric mean differences over 24 hours in log lactate values between the two groups.

Change in Lactate Over 24 Hours

时间窗: 24 hours

Change in median serum lactate level between enrollment and 24-hours after the receipt of study drug. A negative number indicates that the lactate levels were lower at 24 hours compared to their level at receipt of study drug.

次要结局

  • Time ROSC to Target Temperature(Duration of hospitalization, limit 180 days)
  • Survival(Duration of hospitalization, limit 180 days)
  • Number of Participants With Rankin Score ≤3(Duration of hospitalization, limit 180 days)
  • Length of Intensive Care Unit (ICU) Stay(Length of Stay Truncated at 28 Days)
  • Mechanical Ventilation Duration(Duration of hospitalization, limit 180 days)
  • Muscle Weakness Score(Duration of hospitalization, limit 180 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Donnino

Michael Donnino MD

Beth Israel Deaconess Medical Center

研究点 (5)

Loading locations...

相似试验