Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06575101

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Ziren Tang, MD

CONTACT

[email protected]

01085231530

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Target Temperature Management Treatment

Procedure

Target Temperature Management Treatment

Primary outcomes

  1. Resting Energy Expenditure

    Time frame: 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.

  2. Glucose oxidation rate

    Time frame: 7 days

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

  3. Fat oxidation rate

    Time frame: 7 days

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

  4. Protein oxidation rate

    Time frame: 7 days

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

  5. Metabolic supply proportion of glucose, fat, protein

    Time frame: 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.

Secondary outcomes

  1. CPC score

    Time frame: 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.

  2. Mortality rate

    Time frame: 28 days

    The Secondary Outcome of the study is the statistical differences in the mortality rate of two groups at 28 days after CA.

Study contacts

Contact information is provided by the study sponsor or research team.

Ziren Tang, MD

CONTACT

[email protected]

010-85231530

Sponsors and collaborators

Lead sponsor

Tang Ziren

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.