Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis Undergoing Open Necrosectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Measure organ dysfunction change after open necrosectomy with respect to time
研究概览
简要总结
The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy.
详细描述
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). Participants who provide optional consent for biospecimen collection will have peripheral venous blood samples (5-10 mL) collected at predefined preoperative and postoperative time points. Samples will be processed and stored for biomarker analyses, including inflammatory marker measurement, metabolomic profiling, and other exploratory analyses related to the objectives of this study. 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients refuse to participate
- •Patients undergo repeat surgery on the same site
结局指标
主要结局
Measure organ dysfunction change after open necrosectomy with respect to time
时间窗: up to postoperative day 7, or at hospital discharge, whichever comes first
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
次要结局
- The levels of inflammatory factor CRP(preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.)
- The levels of inflammatory procalcitonin(preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.)
- Incidence of ICU mortality(through study completion, an average of 1year)
- Incidence of 28-day mortality(through study completion, an average of 1 year)
- The levels of inflammatory cytokines IL-6(preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.)
- Incidence of one year mortality(through study completion, an average of 1 year)
- incidence of a composite of major complications(up to postoperative day 28)
- Length of hospital stay(through study completion，an average of 1 year)
- Incidence of hospital mortality(through study completion, an average of 1 year)
- ICU length of hospital stay(through study completion, an average of 1 year)
- The pancreatic symptoms score(up to 1 year)
研究者
Chunling Jiang
Professor
West China Hospital