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临床试验/NCT02889744
NCT02889744Unknown不适用

Comparison of Cerebral Tissue Oxygen Saturation (SctO2) Between 36℃ and 33℃ of Targeted Temperature Management (TTM) After Cardiac Arrest

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2016年3月最近更新:
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适应症

试验速览

阶段
不适用
入组人数
66
试验地点
2
主要终点
The comparison of the 72-hour SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The investigators hypothesize that

  1. if decrease in SctO2 level is caused by the degree of hypothermia, SctO2 level in the 33-TH may be lower than that in the 36-TH group.
  2. if decrease in SctO2 level is not caused by the degree of hypothermia but caused by brain injury, SctO2 level may be associated with only the prognosis of cardiac arrest victims regardless of core temperatures.

The primary objective of this study is to compare the 72-hour changes in SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims.

详细描述

  1. Subject Identification and Screening For each cohort, patients will be identified after acquisition of sustained return of spontaneous circulation (ROSC) (> 30 minutes). If the patients meet inclusion/exclusion criteria, patients will be enrolled in the study. The investigators will obtain written informed consent from all of the patients or their representatives.
  2. Assignment of Subject Number A unique identification number will be given to study subjects in an attempt to de-identify their information. Subject numbers will be assigned in sequential order. The subject number will consist of four digits. The first two digits will designate the study site. The last two digits will designate the subject by number in sequential order (i.e., subject number 01 01 will be the first subject at site 1; 01 02 will be the second subject at site 1, etc.).
  3. Study Methods
  • Randomization to 36-TH (core body temperature (BT) 36℃) or 33-TH (core BT 33℃) group will be performed by a web based randomization site (http://mrcc.snuh.org).
  • Start target temperature management using external cooling device (Arctic Sun) within 1 hour post-ROSC.
  • SctO2 monitoring starts within 1 hour post-ROSC and maintain for 72 hours.
  • 36-TH (core BT 36℃) or 33-TH (core BT 33℃) for 24 hours
  • Rewarming 0.25℃/h in 33-TH group
  • Core temperature < 37.5℃ for 72 hours

All patients will be treated per the postresuscitation care protocol. Target treatment will include

  • Target: central venous pressure (CVP) (8 - 12 mmHg), mean arterial pressure (MAP) (> 65 mmHg), central venous oxygen saturation (ScvO2) (> 70%)
  • Seizure control, shivering control as appropriate
  • Coronary intervention as soon as possible if needed
  • Infection control if indicated
  • Other supportive care

Monitoring data including

  • CVP, MAP, ScvO2, lactate, neuron specific enolase (NSE), end-tidal carbon dioxide (EtCO2), input-output (I/O) balance
  • Intermittent electroencephalography (EEG) monitoring (2 times/72 hours)
  • Laboratory data including arterial blood gas analysis (ABGA), complete blood count (CBC), liver function test (LFT), electrolyte, blood urea nitrogen/creatinine (BUN/Cr), et al.
  • SctO2
  • Core (esophageal or bladder) temperature
  1. Data Collection

Study data will be collected in the following manner:

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 (Outcomes Assessor)

盲法说明

Primary and secondary outcomes were assessed by an investigator blinded to this study.

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

  • •Comatose patients successfully resuscitated from cardiac arrest

排除标准

  • •< 18 years old
  • •Definite non-cardiac cause arrest
  • •Contraindication to TH Active bleeding, coagulopathy, fatal arrhythmia, severe infectious condition
  • •Presence of advanced directives to withhold or withdraw life-sustaining treatment
  • •Expected survival < 72 hours
  • •Underlying low CPC (≤ 3)
  • •No informed consent
  • •Follow-up loss

结局指标

主要结局

The comparison of the 72-hour SctO2 level between the 36-TH and 33-TH groups in cardiac arrest victims

时间窗: 72 hour

次要结局

  • The comparison of the 72-hour changes in SctO2 level between the 36-TH and 33-TH groups(0, 24, and 72 hours)
  • The comparison of the serum biomarker levels between the 36-TH and 33-TH groups(0, 24, and 72 hours)
  • The comparison of the severity scores between the 36-TH and 33-TH groups(0, 24, and 72 hours)
  • The comparison of the number of patients with survival discharge between the 36-TH and 33-TH groups(6 months)
  • Complication of therapeutic hypothermia(72 hours)
  • The comparison of the 6-month cerebral performance scale (CPC) between the 36-TH and 33-TH groups(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Comparison of Cerebral SctO2 Between 36℃ and 33℃ of... | 临床试验