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NCT Number: NCT07201246

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Necrotizing Pancreatitis patients' organdysfunction progression

Other

Study the dynamic nature of organ dysfunction

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of ICU mortality

    Time frame: an average of 1year

  2. Incidence of hospital mortality

    Time frame: an average of 1 year

  3. Incidence of 28-day mortality

    Time frame: an average of 1 year

  4. Incidence of one year mortality

    Time frame: an average of 1 year

  5. ICU length of hospital stay

    Time frame: an average of 1 year

  6. Length of hospital stay

    Time frame: an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Chunling Jiang, PhD

CONTACT

[email protected]

02885423593

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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