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The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatitis with sepsis patients' organ dysfunction progression after open necrosectomy | Acute necrotizing pancreatitis patients with sepsis undergoing open necrosectomy will be measured SOFA scores at a special time point to characterize organ dysfunction experience profiles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Necrotizing Pancreatitis patients' organ dysfunction progression | Other | Study the dynamic nature of organ dysfunction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to postoperative day 7, or at hospital discharge, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of a composite of major complications | Major complications were defined as new-onset organ failure (ie, cardiovascular, pulmonary, or renal) | up to postoperative day 28 |
| Incidence of ICU mortality |
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Inclusion Criteria:
Exclusion Criteria:
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Acute necrotizing pancreatitis Patients with sepsis scheduled for open necrosectomy will be invited to participate in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunling Jiang, PhD | Contact | 18980601096 | jiangchunling@scu.edu.cn | |
| Qian Li, PhD | Contact | 18980601096 | jiangchunling@scu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fengming Luo, PhD | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | China | 610041 | China |
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| ID | Term |
|---|---|
| D019283 | Pancreatitis, Acute Necrotizing |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D007239 | Infections |
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Death occurred in ICU
| through study completion, an average of 1year |
| Incidence of hospital mortality | Death occurred in hospital | through study completion, an average of 1 year |
| Incidence of 28-day mortality | Death occurred within 28-day after surgery | through study completion, an average of 1 year |
| Incidence of one year mortality | Death occurred within one year after surgery | through study completion, an average of 1 year |
| ICU length of hospital stay | Determined by the number of days from ICU admittance to discharge from ICU | through study completion, an average of 1 year |
| Length of hospital stay | Determined by the number of days from admittance to discharge | through study completion，an average of 1 year |
| The pancreatic symptoms score | Pancreatic symptom scores will be measured at preoperative, postoperative day 1, day 2, day 3, day 7, or at hospital discharge, whichever comes first, at 1 month, 3 months, 6 months, and 1 year postoperatively. Both were measured using the Patient-Reported Outcome Scale, which ranges from 0 to 10 for each symptom; The overall range is from 0 to 70, with higher scores indicating higher symptom intensity. | up to 1 year |
| The levels of inflammatory factor CRP | Peripheral blood CRP | preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first. |
| The levels of inflammatory cytokines IL-6 | cytokines IL-6 | preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first. |
| The levels of inflammatory procalcitonin | procalcitonin was measured at preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first. | preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first. |
| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |