Effect of Target Temperature Management on Intestinal Flora and Its Metabolites in Patients With Cardiac Arrest

NCT06974682 | Not Yet Recruiting DMC

• 1 other identifier: 2025-4-10-8
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Intestinal flora structure

  Diversity of intestinal flora

  one year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.

You may qualify if:

• (1).18 years old and above; (2) Successful resuscitation after cardiopulmonary resuscitation (including chest compressions, electric shock defibrillation, etc.) and target temperature management;

You may not qualify if:

• (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;

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing chaoyang hospital, Beijing, Beijing 100020

Beijing, China

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Ziren Tang

CONTACT

+86 010-85231530; tangziren1970@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

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

Locations

CN (1)