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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest; Nutrition; Resting Energy Expenditure; Targeted Temperature Management
• Intervention / Treatment: Procedure: Target Temperature Management Treatment

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Ziren Tang, MD; Phone Number: 010-85231530; Email: tangziren1970@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Chao-Yang Hospital, Capital Medical University
      • Contact: Ziren Tang, MD; Phone Number: 01085231530; Email: tangziren1970@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients(age >18 years) who have been successfully resuscitated from cardiac arrest who meet the inclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
33℃ group	Procedure: Target Temperature Management Treatment; Target Temperature Management Treatment
36℃ group	Procedure: Target Temperature Management Treatment; Target Temperature Management Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Energy Expenditure	The primary outcome measure is the changes resting energy expenditure(REE) in the patients at various time points. patients at various time points.	7 days
Glucose oxidation rate	The primary outcome measure is the statistical differences in Glucose oxidation rate between the two groups of patients at various time points.	7 days
Fat oxidation rate	The primary outcome measure is the statistical differences in fat oxidation rate between the two groups of patients at various time points.	7 days
Protein oxidation rate	The primary outcome measure is the statistical differences in protein oxidation rate between the two groups of patients at various time points.	7 days
Metabolic supply proportion of glucose, fat, protein	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPC core	CPC = Cerebral Performance Category Score. The Secondary Outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 28 days after CA.	28 days
Mortality rate	The Secondary Outcome of the study is the statistical differences in the mortality rate of two groups at 28 days after CA.	28 days

Collaborators and Investigators

• Sponsor: Tang Ziren

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 2024-4-15-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: The identified survey data will be made available for research purposes by contacting the corresponding authors
• IPD Sharing Supporting Information Type: SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No