Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients

September 15, 2026 updated by: Huang YuGuang, Peking Union Medical College Hospital
An observational cohort was established using preoperatively collected biospecimens and prospectively ascertained postoperative outcomes. A nested case-control metagenomic analysis was subsequently conducted within the cohort, including participants with grade II or higher PPCs and selected participants without PPCs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Department of Anesthesiology, Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Elderly patients over 65 years old who plan to undergo elective major abdominal surgery

Description

Inclusion Criteria:

  1. Age: ≥ 65 years old;
  2. Surgery: Major abdominal surgery (expected duration ≥ 2 hours);
  3. Anesthesia methods: general anesthesia, tracheal intubation;
  4. ASA classification: I-IV levels;
  5. Postoperative Pulmonary Complications Risk Score (ARISCAT): Medium to High Risk
  6. Patients or their families are able to understand the research protocol and are willing to participate in this study, providing written informed consent

Exclusion Criteria:

  1. Emergency surgery;
  2. This is the second surgery within the past month;
  3. Preoperative presence of pulmonary infection or other serious pulmonary complications
  4. Patients who have used antibiotics, probiotics, and acid suppressants within one month before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly surgical patients
Adults aged 65 years or older undergoing major non-cardiac surgery of expected duration of at least 2 hours under general anesthesia with tracheal intubation. Participants are followed for postoperative pulmonary complications within 7 days after surgery, and preoperative biospecimens are collected when feasible with participant consent.
Procedure: Elective abdominal surgery
The included elderly patients are those who are preparing for elective abdominal surgery and the surgery time exceeds 2 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with postoperative pulmonary complications
Time Frame: Within 7 days after surgery
The primary outcome is the occurrence of one or more ppcs, including primarily hypoxemia, atelectasis, and pneumonia, etc.
Within 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of inflammatory cytokines in peripheral blood before and after surgery
Time Frame: Before and within 7 days after surgery
Inflammatory factors include high-sensitivity C-reactive protein (CRP) and procalcitonin (PCT)
Before and within 7 days after surgery
Preoperative gut microbiome composition
Time Frame: Preoperative, before bowel preparation and prophylactic antibiotics
Taxonomic composition and relative abundance derived from shotgun metagenomic sequencing of eligible preoperative faecal samples.
Preoperative, before bowel preparation and prophylactic antibiotics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • K5484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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