Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy

NCT06380842 | Recruiting

• 1 other identifier: 2023HX1970
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy.

Conditions

Necrotizing Pancreatitis

Keywords

Acute Necrotizing Pancreatitis; sepsis; organ dysfunction

Outcome Measures

Primary Outcomes (1)

• Measure organ dysfunction change after open necrosectomy with respect to time

  Organ dysfunction will be measured using sequential organ failure assessment score scale. The scores range from 0 (normal) to 4(most abnormal) for each organ, with higher scores indicating worse health status

  up to postoperative day 7, or at hospital discharge, whichever comes first

Secondary Outcomes (11)

• incidence of a composite of major complications

  up to postoperative day 28

• Incidence of ICU mortality

  through study completion, an average of 1year

• Incidence of hospital mortality

  through study completion, an average of 1 year

• Incidence of 28-day mortality

  through study completion, an average of 1 year

• Incidence of one year mortality

  through study completion, an average of 1 year

Study Arms (1)

Pancreatitis with sepsis patients' organ dysfunction progression after open necrosectomy

Acute necrotizing pancreatitis patients with sepsis undergoing open necrosectomy will be measured SOFA scores at a special time point to characterize organ dysfunction experience profiles.

Other: Necrotizing Pancreatitis patients' organ dysfunction progression

Interventions

Necrotizing Pancreatitis patients' organ dysfunction progression OTHER

Study the dynamic nature of organ dysfunction

Pancreatitis with sepsis patients' organ dysfunction progression after open necrosectomy

Eligibility Criteria

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

Study Population

Acute necrotizing pancreatitis Patients with sepsis scheduled for open necrosectomy will be invited to participate in this study.

You may qualify if:

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

You may not qualify if:

• Patients refuse to participate
• Patients undergo repeat surgery on the same site

Sponsors & Collaborators

• Chunling Jiang: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, China, 610041, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Sepsis

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fengming Luo, PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunling Jiang, PhD

CONTACT

18980601096; jiangchunling@scu.edu.cn

Qian Li, PhD

CONTACT

18980601096; jiangchunling@scu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 24, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)