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NCT Number: NCT06974682

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

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.

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Key information

Conditions

Cardiac Arrest (CA) Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • (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;

Treatment and study plan

Primary outcomes

  1. Intestinal flora structure

    Time frame: one year

    Diversity of intestinal flora

Study contacts

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

Ziren Tang

CONTACT

[email protected]

+86 010-85231530

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 16, 2025
Registry last updated
Aug 27, 2025

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.

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