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

Recruiting

• Conditions: Cardiac Arrest; Nutrition; Resting Energy Expenditure; Targeted Temperature Management
• Interventions: Procedure: Target Temperature Management Treatment

• Registration Number: NCT06575101
• Lead Sponsor: Tang Ziren

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-25
• Last Update Submitted: 2024-08-25
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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);

Exclusion Criteria

• 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；

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
33℃ group	Target Temperature Management Treatment	-
36℃ group	Target Temperature Management Treatment	-

Primary Outcome Measures

Name	Time	Method
Resting Energy Expenditure	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	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	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	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	7 days	The primary outcome measure is the statistical differences in Glucose oxidation rate between the two groups of patients at various time points.

Secondary Outcome Measures

Name	Time	Method
CPC score	28 days	CPC = Cerebral Performance Category Score.There are 5 levels of CPC score. CPC 1-2 means good prognosis of neurological function, CPC3-5 means bad prognosis of neurological function. The Secondary Outcome of the study is the statistical differences in the proportion of patients with good neurological outcome(CPC1-2) in the two groups at 28 days after CA.
Mortality rate	28 days	The Secondary Outcome of the study is the statistical differences in the mortality rate of two groups at 28 days after CA.

Trial Locations

Locations (1)

Beijing chao-yang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China