Organ Dysfunction Changes in Acute Necrotizing Pancreatitis Patients With Sepsis Following Open Necrosectomy

September 23, 2025 updated by: Chunling Jiang, West China Hospital

Retrospective Analysis of Organ Dysfunction Changes in Acute Necrotizing Pancreatitis Patients With Sepsis Following Open Necrosectomy：A Retrospective Cohort Study

The purpose of this retrospective study was to characterize the changes in organ dysfunction among patients with acute necrotizing pancreatitis complicated by sepsis who underwent open necrosectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Baseline demographic and clinical characteristics (including age, gender, and education level) were collected from medical records. Organ dysfunction was defined according to the Sequential Organ Failure Assessment (SOFA) score. SOFA scores were extracted at predefined time points: preoperative (T1), postoperative day 1 (T2), postoperative day 3 (T3), and either postoperative day 7 or hospital discharge, whichever occurred first (T4). Postoperative survival status up to 1 year was obtained from the institutional database.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • China
      • Chengdu, China, China, 610041
        • West China Hospital, Sichuan University
        • Contact:

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

Probability Sample

Study Population

This retrospective cohort included patients with acute necrotizing pancreatitis complicated by sepsis who underwent open necrosectomy

Description

Inclusion Criteria:

  1. Patients 18 years or older
  2. Diagnosis of Acute pancreatitis according to the revised Atlanta classification, requires two of thefollowing three criteria: (A) typical abdominal pain, (B) an increase in serum amylase or lipaselevels higher than three times the upper limit of normality, and (C) signs of AP in imaging3)Patients with confirmed or suspected infected pancreatic or peripancreatic necrosis werescheduled for open necrosectomy
  3. Meet Sepsis-3 criteria

Exclusion Criteria:

Patients undergo repeat surgery on the same site

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
Pancreatitis with sepsis patients' organdysfunction progression after opennecrosectomy
SOFA scores at predefined time points were retrospectively extracted from the institutional database in acute necrotizing pancreatitis patients with sepsis who underwent open necrosectomy to characterize organ dysfunction trajectories
Other: Necrotizing Pancreatitis patients' organdysfunction progression
Study the dynamic nature of organ dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure organ dysfunction change after open necrosectomy with respect to time
Time Frame: up to postoperative day 7, or at hospital discharge, whichever comes first
Organ dysfunction was assessed retrospectively using the Sequential Organ Failure Assessment (SOFA) score, which ranges from 0 (normal) to 4 (most abnormal) for each organ, with higher scores indicating more severe dysfunction.
up to postoperative day 7, or at hospital discharge, whichever comes first

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of ICU mortality
Time Frame: an average of 1year
an average of 1year
Incidence of hospital mortality
Time Frame: an average of 1 year
an average of 1 year
Incidence of 28-day mortality
Time Frame: an average of 1 year
an average of 1 year
Incidence of one year mortality
Time Frame: an average of 1 year
an average of 1 year
ICU length of hospital stay
Time Frame: an average of 1 year
an average of 1 year
Length of hospital stay
Time Frame: an average of 1 year
an average of 1 year

Collaborators and Investigators

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

Sponsor

West China 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 (Estimated)

October 5, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

September 18, 2025

First Submitted That Met QC Criteria

September 23, 2025

First Posted (Estimated)

October 1, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-162

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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