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临床试验/NCT06575101
NCT06575101招募中不适用

Resting Energy Expenditure and Substrate Consumption in Cardiac Arrest Patients Under Target Temperature Management

Tang Ziren1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Resting Energy Expenditure

研究概览

简要总结

This study is a single-center, prospective, observational study. According to the sample size formula, an estimated 40 cases should be collected, all of whom are from the emergency intensive care unit. After successful cardiopulmonary resuscitation, the enrolled patients will be transferred to the emergency intensive care unit for further standardized target temperature management (TTM). They will be divided into 33 ° C hypothermia group and 36 ° C hypothermia group according to the patient's core body temperature. The baseline data of the patients will be collected at the beginning. After admission to the hospital, they were fasted within 24 hours to reach the target temperature, and then 20kcal/kg/d parenteral nutrition will be given. At selected time points (T0: the initial time point before TTM; T1: the core temperature was reduced to 33 ° C or 36 ° C; T2-T4: 33 ° C or 36 ° C was maintained for 24h, 48h, 72h; T5: the end of rewarming; Tend: the last REE measurement before discharge or death) , various observation indicators will be collected, including resting energy expenditure (REE), glucose oxidation rate, fat oxidation rate, protein oxidation rate, and metabolism of three major nutrients Proportion. Neurological outcomes were followed up 28 days after onset according to the Cerebral Performance Categories (CPC) score.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • •Be admitted to the emergency department of Beijing Chao-yang Hospital, Capital Medical University;
  • •Successfully resuscitated, and are unconscious after restoration of spontaneous circulation (ROSC);
  • •Be admitted to the intensive care unit (ICU) for advanced life support such as endotracheal intubation after restoration of spontaneous circulation (ROSC);
  • •Accepted target temperature management (TTM) therapy after restoration of spontaneous circulation (ROSC);

排除标准

  • •Age > 18 years old;
  • •Incomplete clinical data and loss of follow-up;
  • •Traumatic brain injury or cerebrovascular accident revealed by computed tomography (CT);
  • •Severe metabolic abnormalities are known: cachexia, thyroid dysfunction, and cancer;
  • •Indirect calorimetry measurement is not possible such as sustained oxygen concentration > 70%;
  • •There were no signs of resuscitation at the time of admission;

研究组 & 干预措施

33℃ group

干预措施: Target Temperature Management Treatment (Procedure)

36℃ group

干预措施: Target Temperature Management Treatment (Procedure)

结局指标

主要结局

Resting Energy Expenditure

时间窗: 7 days

The primary outcome measure is the changes resting energy expenditure(REE) in the patients at various time points. patients at various time points.

Protein oxidation rate

时间窗: 7 days

The primary outcome measure is the statistical differences in protein oxidation rate between the two groups of patients at various time points.

Fat oxidation rate

时间窗: 7 days

The primary outcome measure is the statistical differences in fat oxidation rate between the two groups of patients at various time points.

Metabolic supply proportion of glucose, fat, protein

时间窗: 7 days

The primary outcome measure is the statistical differences in metabolic supply proportion of glucose, fat, protein (measuring by indirect calorimetry) between the two groups of patients at various time points.

Glucose oxidation rate

时间窗: 7 days

The primary outcome measure is the statistical differences in Glucose oxidation rate between the two groups of patients at various time points.

次要结局

  • CPC score(28 days)
  • Mortality rate(28 days)

研究者

发起方
Tang Ziren
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tang Ziren

Professor

Capital Medical University

研究点 (1)

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