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

NCT06575101 | Recruiting

• 1 other identifier: 2024-4-15-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Targeted Temperature Management; Cardiac Arrest; Resting Energy Expenditure; Nutrition

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• CPC score

  28 days

• Mortality rate

  28 days

Study Arms (2)

33℃ group

Procedure: Target Temperature Management Treatment

36℃ group

Procedure: Target Temperature Management Treatment

Interventions

Target Temperature Management Treatment PROCEDURE

Target Temperature Management Treatment

33℃ group; 36℃ group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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);

You may not qualify if:

• 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；

Sponsors & Collaborators

• Tang Ziren: lead

Study Sites (1)

Beijing chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Ziren Tang, MD

CONTACT

010-85231530; tangziren1970@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 28, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: The identified survey data will be made available for research purposes by contacting the corresponding authors

Locations

CN (1)