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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07201246
Enrollment
700
Registered
2025-10-01
Start date
2025-10-05
Completion date
2026-12-30
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Pancreatitis

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.

Interventions

OTHERNecrotizing Pancreatitis patients' organdysfunction progression

Study the dynamic nature of organ dysfunction

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure organ dysfunction change after open necrosectomy with respect to timeup to postoperative day 7, or at hospital discharge, whichever comes firstOrgan 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

MeasureTime frame
Incidence of hospital mortalityan average of 1 year
Incidence of 28-day mortalityan average of 1 year
Incidence of ICU mortalityan average of 1year
ICU length of hospital stayan average of 1 year
Length of hospital stayan average of 1 year
Incidence of one year mortalityan average of 1 year

Countries

China

Contacts

Primary ContactChunling Jiang, PhD
jiangchunling@scu.edu.cn02885423593

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026