Clinical Characteristics and Risk Factors for In-Hospital Mortality in Surgical Patients With Abdominal Sepsis

March 25, 2025 updated by: Jingsheng Lou, Chinese PLA General Hospital

Intraoperative Low-dose Glucocorticoids in Surgical Patients With Abdominal Sepsis: A Multicenter Retrospective Cohort Study

A retrospective study of sepsis patients with abdominal infections who underwent abdominal surgery was conducted in an attempt to reveal the epidemiological characteristics of sepsis after abdominal surgery, risk factors, and to analyze the prognosis of the patients, to reveal indicators of predictive value for the prognosis of patients with sepsis, with a view to providing certain evidence for optimizing the perianesthesia management of patients with sepsis.

Study Overview

Status

Completed

Conditions

Detailed Description

Background and Aims: Abdominal sepsis refers to a severe and potentially life-threatening condition characterized by the presence of infection, inflammation, and tissue damage within the abdominal cavity. Glucocorticoids (GCs) play an important role in regulation of the host immune and inflammation responses involved in sepsis and surgery. This study aimed to investigate the potential impact of intraoperative GCs administration on the clinical outcome of surgical patients with abdominal sepsis.

Methods: This retrospective cohort study included a 1:1 propensity score-matched cohort of surgical patients afflicted with abdominal sepsis at 2 medical centers from January, 2008, through December, 2022. Patients were classified into low-GCs, high-GCs, and non-GCs groups according to the dosage of steroids used intraoperatively, and in-hospital mortality was designated as the primary outcome.

Study Type

Observational

Enrollment (Actual)

476

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
      • Beijing, Beijing, China, 100853/100142
        • Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital /Depatment of Anesthesiology, The Air Force Medical Center

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Abdominal septic patients underwent surgical procedures in two large-scale medical centers (the First Medical Center of the Chinese People's Liberation Army [PLA] General Hospital and the Air Force Medical Center) between Jan, 2008 and Dec, 2022 in Beijing, China.

Description

Inclusion Criteria:

  • Meeting the Sepsis 3.0 criteria ;
  • Patient's age ≥ 18 years;
  • Emergency or elective abdominal surgery.

Exclusion Criteria:

  • History of severe cardiopulmonary, hepatic, renal, or other organ damage;
  • Preoperative presence of infection other than abdominal;
  • Unplanned secondary surgery；
  • Receiving preoperative glucocorticoid therapy.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-hospital mortality
Time Frame: January 2008 - December 2022
January 2008 - December 2022

Collaborators and Investigators

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

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Chair: Weidong Mi, Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General 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)

November 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAGH-AOC-L06

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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