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

NCT06684340 | Completed DMC

• 1 other identifier: XH-24-009
• Study Type: observational
• Target: 22,646
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sepsis; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Sepsis within 28 days after 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

Interventions

Exposure to major abdominal surgery PROCEDURE

This study is a retrospective cohort study. The 'exposure' situation is based on historical records and observation, and no active intervention has been conducted on the study subjects to change their exposure status.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing major abdominal surgery.
• 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.
• The anesthesiologist performing the operation has more than 5 years of clinical experience.
• All surgical patients receive general anesthesia.

You may not qualify if:

• \. 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).
• \. 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).

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

MeSH Terms

Conditions

Sepsis; Postoperative Complications

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 12, 2024
• Study Start: January 1, 2014
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share