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

Not yet recruiting

• Conditions: Necrotizing Pancreatitis

• Registration Number: NCT07201246
• Lead Sponsor: West China Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-18
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2025-10-05
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure organ dysfunction change after open necrosectomy with respect to time	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of ICU mortality	an average of 1year
Incidence of 28-day mortality	an average of 1 year
ICU length of hospital stay	an average of 1 year
Incidence of hospital mortality	an average of 1 year
Incidence of one year mortality	an average of 1 year
Length of hospital stay	an average of 1 year

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China, China