Targeted Temperature ManagementNCT06575101
Resting Energy Expenditure and Substrate Consumption in Cardiac Arrest Patients Under Target Temperature Management
An observational study of Targeted Temperature Management and Cardiac Arrest, run by Tang Ziren at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Targeted Temperature Management, Cardiac Arrest, Resting Energy Expenditure
- What is being tested?
- Target Temperature Management Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients(age >18 years) who have been successfully resuscitated from cardiac arrest who meet the inclusion criteria.
Who may be able to join
- 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);
Who cannot join
- 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；
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality
Ziren Tang, MD, 01085231530, tangziren1970@163.com
About this study
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.
- Being tested
- Target Temperature Management Treatment
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target Temperature Management TreatmentProcedure or surgery
Target Temperature Management Treatment
| Study group | Role | What they receive |
|---|---|---|
| 33℃ group | Not described Receives: Procedure: Target Temperature Management Treatment | |
| 36℃ group | Not described Receives: Procedure: Target Temperature Management Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days
Secondary outcomes (2)
CPC score
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.
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Targeted Temperature ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang Ziren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tang Ziren, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575101
- Sponsor's protocol ID
- 2024-4-15-1
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Energy Expenditure and Substrate Consumption in Cardiac Arrest Patients Under Target Temperature Management
- ClinicalTrials.gov ID
- NCT06575101
- Acronym / sponsor ID
- 2024-4-15-1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tang ZirenUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 33℃ group | – | Procedure: Target Temperature Management Treatment |
| 36℃ group | – | Procedure: Target Temperature Management Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients(age >18 years) who have been successfully resuscitated from cardiac arrest who meet the inclusion criteria.
Key inclusion criteria (4 listed)
- 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);
Key exclusion criteria (6 listed)
- 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%；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target Temperature Management TreatmentTarget Temperature Management Treatment | Procedure or surgery | 33℃ group, 36℃ group |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
CPC score
Time frame: 28 days
Mortality rate
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Targeted Temperature Management and Cardiac Arrest, run by Tang Ziren at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziren Tang, MD (010-85231530, tangziren1970@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Energy Expenditure (time frame: 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.