Clinical trial NCT06380842: Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy
Official title: Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis Undergoing Open Necrosectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Necrotizing Pancreatitis
Keywords: Acute Necrotizing Pancreatitis
sepsis
organ dysfunction
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute necrotizing pancreatitis Patients with sepsis scheduled for open necrosectomy will be invited to participate in this study.

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

Detailed description: Before surgery, study participants will be asked questions about age, gender, education level, etc. Study participants will also be questioned regarding pancreatic symptoms, as measured on the patient-Reported Outcome Scale in Acute Pancreatitis (including, pain, abdominal distention, eating, bowel movements, nausea and vomiting, thirst, and weakness). Organ dysfunction was defined according to the sequential organ failure assessment (SOFA) score. The SOFA score will be measured at preoperative (T1), postoperative day 1 (T2), postoperative day 3 (T3), postoperative day 7, or at hospital discharge, whichever comes first (T4). Following discharge from the hospital, study participants will be contacted at 1 month, 3 months, 6 months, and 1 year after surgery, and asked to complete a survey about their pancreatic symptoms and survival status after surgery.

Eligibility criteria: Inclusion Criteria:

1. Patients 18 years or older
2. 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
3. Patients with confirmed or suspected infected pancreatic or peripancreatic necrosis were scheduled for open necrosectomy
4. Meet Sepsis-3 criteria

Exclusion Criteria:

1. Patients refuse to participate
2. Patients undergo repeat surgery on the same site

Primary outcomes:
measure: Measure organ dysfunction change after open necrosectomy with respect to time
timeFrame: up to postoperative day 7, or at hospital discharge, whichever comes first
Secondary outcomes:
measure: incidence of a composite of major complications
timeFrame: up to postoperative day 28
measure: Incidence of ICU mortality
timeFrame: through study completion, an average of 1year
measure: Incidence of hospital mortality
timeFrame: through study completion, an average of 1 year
measure: Incidence of 28-day mortality
timeFrame: through study completion, an average of 1 year
measure: Incidence of one year mortality
timeFrame: through study completion, an average of 1 year
measure: ICU length of hospital stay
timeFrame: through study completion, an average of 1 year
measure: Length of hospital stay
timeFrame: through study completion，an average of 1 year
measure: The pancreatic symptoms score
timeFrame: up to 1 year
measure: The levels of inflammatory factor CRP
timeFrame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
measure: The levels of inflammatory cytokines IL-6
timeFrame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
measure: The levels of inflammatory procalcitonin
timeFrame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Fengming Luo, PhD
role: PRINCIPAL_INVESTIGATOR
References: