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

Observational Necrotizing Pancreatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Necrotizing Pancreatitis patients' organdysfunction progression.
Who it may be relevant to
Registry conditions: Necrotizing Pancreatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Necrotizing Pancreatitis patients' organdysfunction progression
    Study the dynamic nature of organ dysfunction

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Incidence of ICU mortality [Time frame: an average of 1year]
  • Incidence of hospital mortality [Time frame: an average of 1 year]
  • Incidence of 28-day mortality [Time frame: an average of 1 year]
  • Incidence of one year mortality [Time frame: an average of 1 year]
  • ICU length of hospital stay [Time frame: an average of 1 year]
  • Length of hospital stay [Time frame: an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Patients 18 years or older
  • 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
  • Meet Sepsis-3 criteria

Exclusion criteria

Patients undergo repeat surgery on the same site

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • West China Hospital, Sichuan University — Chengdu

Identifiers

NCT: NCT07201246 · 2024-162

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗