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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChunling Jiang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients refuse to participate

Patients undergo repeat surgery on the same site

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Necrotizing Pancreatitis patients' organ dysfunction progression

    Other intervention

    Study the dynamic nature of organ dysfunction

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Pancreatitis with sepsis patients' organ dysfunction progression after open necrosectomy1 intervention

Trial outcomes

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

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

Secondary outcomes

1

incidence of a composite of major complications

Major complications were defined as new-onset organ failure (ie, cardiovascular, pulmonary, or renal)

Time frame
up to postoperative day 28
2

Incidence of ICU mortality

Death occurred in ICU

Time frame
through study completion, an average of 1year
3

Incidence of hospital mortality

Death occurred in hospital

Time frame
through study completion, an average of 1 year
4

Incidence of 28-day mortality

Death occurred within 28-day after surgery

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chunling Jiang

Lead sponsor

West China Hospital

Sponsor institution