Resting Energy Expenditure and Substrate Consumption in Cardiac Arrest Patients Under Target Temperature Management
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Ziren Tang, MD
- Phone Number: 010-85231530
- Email: tangziren1970@163.com
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China
- Recruiting
- Beijing Chao-Yang Hospital, Capital Medical University
-
Contact:
- Ziren Tang, MD
- Phone Number: 01085231530
- Email: tangziren1970@163.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
33℃ group
|
Target Temperature Management Treatment
|
|
36℃ group
|
Target Temperature Management Treatment
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
7 days
|
|
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.
|
7 days
|
|
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.
|
7 days
|
|
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.
|
7 days
|
|
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.
|
7 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
28 days
|
|
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.
|
28 days
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2024-4-15-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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