Risk Factors Identification of Sepsis and Septic Shock After Major Abdominal Surgery Based on Artificial Intelligence

November 10, 2024 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Construction of AI-enabled Models for Predicting the Risk of Sepsis After Major Abdominal Surgery: a Retrospective Multicenter Clinical Study

The goal of this observational study is to identify the risk factors and build the early warning system of sepsis and septic shock after major abdominal surgery based on artificial intelligence. The main questions it aims to answer are:

What are the high risk factors of postoperative sepsis? Which factors can accelerate the progression of sepsis? Researchers will collect perioperative characteristics to construct predictive models of postoperative sepsis in a retrospective abdominal surgical population based on artificial intelligence, and the accuracy of the models were tested in an external dataset.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22646

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

Internal Cohort: Patients who received major abdominal surgery in each participating hospital before June 2024.

External Cohort: Patients who received major abdominal surgery, received general anesthesia, and were aged 18 years or older from 2008 to 2019. The data was extracted from the MIMIC - IV (Medical Information Mart for Intensive Care, 2.2 version) database.

Description

Inclusion Criteria：

  1. Patients undergoing major abdominal surgery.
  2. The surgeon performing the operation has extensive experience in specialized surgeries such as upper gastrointestinal, hepatobiliary and pancreatic, colorectal, gynecological, and urological surgeries, having completed at least 50 corresponding specialized surgical cases.
  3. The anesthesiologist performing the operation has more than 5 years of clinical experience.
  4. All surgical patients receive general anesthesia.
  5. Patients are aged ≥ 18 years. Exclusion Criteria：

1. Pregnancy-related surgeries (cesarean section, abortion surgery). 2. Patients with known preoperative infection or suspected infection. 3. Severely malnourished patients (BMI reference values are 17 kg/m² for patients < 70 years old and 17.8 kg/m² for patients > 70 years old).

4. Patients who have previously undergone abdominal surgery. 5. Patients without sufficient data, including demographic variables (such as age, gender), surgical details (surgery duration, surgical grade, anesthesia grade, anesthesia duration), and hospitalization details (such as ICU stay, in-hospital mortality).

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
Measure Description
Time Frame
Sepsis within 28 days after surgery.
Time Frame: In the 28-day period following surgery
For patients within 28 days after surgery, if there is a recorded or suspected infection and the Sequential Organ Failure Assessment (SOFA) score is ≥ 2 points, sepsis can be diagnosed. For sepsis patients, if they still have persistent hypotension after adequate volume resuscitation and require vasopressor drugs to maintain a Mean Atrial Pressure (MAP) ≥ 65 mmHg and a serum lactate level > 2 mmol/L, it is considered that the sepsis patient has progressed to septic shock.
In the 28-day period following surgery

Collaborators and Investigators

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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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)

January 1, 2014

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

November 3, 2024

First Submitted That Met QC Criteria

November 10, 2024

First Posted (Estimated)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-24-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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