Cardiac Arrest (CA)NCT06974682
Effect of Target Temperature Management on Intestinal Flora and Its Metabolites in Patients With Cardiac Arrest
An observational study of Cardiac Arrest (CA), run by Capital Medical University at 1 site in China.
Trial summary
Based on the self-control design, this study explored the dynamic regulation of target temperature management therapy (TTM) on intestinal flora structure and metabolites of patients after cardiopulmonary resuscitation (CPR). This study is a single-center prospective observational study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest (CA)
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Jun 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.
Who may be able to join
- (1).18 years old and above; (2) Successful resuscitation after cardiopulmonary resuscitation (including chest compressions, electric shock defibrillation, etc.) and target temperature management;
Who cannot join
- (1) Pregnant or lactating women; (2) Patients with intestinal dysfunction: including severe acute intestinal injury, intestinal obstruction or other diseases that affect the normal function of the intestine; (3) Immunosuppression status: such as patients who use immunosuppressants, or patients with obvious immune dysfunction (such as HIV infection, organ transplant patients, etc.); (4) Those who have recently undergone intestinal surgery or endoscopy; (5) The patient or his family failed to sign the informed consent or refused to participate in the study;
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
Beijing chaoyang hospital, Beijing, Beijing 100020
Beijing
ziqi zhong, +86 18346456166, 18346456166@163.com
About this study
Based on the self-control design, this study explored the dynamic regulation of target temperature management therapy (TTM) on intestinal flora structure and metabolites of patients after cardiopulmonary resuscitation (CPR). This study is a single-center prospective observational study. Patients with spontaneous circulation recovery (ROSC) after CPR and TTM were included before and after self-hypothermia treatment, and the time series changes of intestinal flora and metabolites at some representative time points before and after treatment were compared. Thirty-five adult patients (age ≥18 years) who met the admission criteria were included. Before TTM treatment (0h after ROSC, baseline), 48 h after TTM warming (T1) and 48 h after rewarming (T2), fecal samples (macro-gene sequencing) and blood samples (metabonomics) were collected to analyze the changes of intestinal flora and metabolites in patients with cardiac arrest, and to screen the differential flora and metabolites regulated by TTM and their dynamic correlation.
- Conditions
- Cardiac Arrest (CA)
- Keywords
- Cardiac Arrest, intestinal flora, Intestinal metabolites, Macrogenome
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal flora structure
Diversity of intestinal flora
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Ziren, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974682
- Sponsor's protocol ID
- 2025-4-10-8
- Status last verified
- Aug 2025
- First submitted
- 8 May 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Target Temperature Management on Intestinal Flora and Its Metabolites in Patients With Cardiac Arrest
- ClinicalTrials.gov ID
- NCT06974682
- Acronym / sponsor ID
- 2025-4-10-8
- Conditions
- Cardiac Arrest (CA)
- Keywords
- Cardiac Arrest, intestinal flora, Intestinal metabolites, Macrogenome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 May 2025 (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.
Based on the self-control design, this study explored the dynamic regulation of target temperature management therapy (TTM) on intestinal flora structure and metabolites of patients after cardiopulmonary resuscitation (CPR). This study is a single-center prospective observational study. Patients with spontaneous circulation recovery (ROSC) after CPR and TTM were included before and after self-hypothermia treatment, and the time series changes of intestinal flora and metabolites at some representative time points before and after treatment were compared. Thirty-five adult patients (age ≥18 years) who met the admission criteria were included. Before TTM treatment (0h after ROSC, baseline), 48 h after TTM warming (T1) and 48 h after rewarming (T2), fecal samples (macro-gene sequencing) and blood samples (metabonomics) were collected to analyze the changes of intestinal flora and metabolites in patients with cardiac arrest, and to screen the differential flora and metabolites regulated by TTM and their dynamic correlation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.
Key inclusion criteria (1 listed)
- (1).18 years old and above; (2) Successful resuscitation after cardiopulmonary resuscitation (including chest compressions, electric shock defibrillation, etc.) and target temperature management;
Key exclusion criteria (1 listed)
- (1) Pregnant or lactating women; (2) Patients with intestinal dysfunction: including severe acute intestinal injury, intestinal obstruction or other diseases that affect the normal function of the intestine; (3) Immunosuppression status: such as patients who use immunosuppressants, or patients with obvious immune dysfunction (such as HIV infection, organ transplant patients, etc.); (4) Those who have recently undergone intestinal surgery or endoscopy; (5) The patient or his family failed to sign the informed consent or refused to participate in the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intestinal flora structure
Time frame: one year
Diversity of intestinal flora
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 27 Aug 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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 Cardiac Arrest (CA), run by Capital Medical University 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Aug 2025. 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 (+86 010-85231530, tangziren1970@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal flora structure (time frame: one year). 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 27 Aug 2025.