West China Hospital, Sichuan University
Chengdu, China, 610041
Location status: Recruiting
NCT Number: NCT06380842
The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Chengdu, China, 610041
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study the dynamic nature of organ dysfunction
Time frame: 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
Time frame: up to postoperative day 28
Major complications were defined as new-onset organ failure (ie, cardiovascular, pulmonary, or renal)
Time frame: through study completion, an average of 1year
Death occurred in ICU
Time frame: through study completion, an average of 1 year
Death occurred in hospital
Time frame: through study completion, an average of 1 year
Death occurred within 28-day after surgery
Time frame: through study completion, an average of 1 year
Death occurred within one year after surgery
Time frame: through study completion, an average of 1 year
Determined by the number of days from ICU admittance to discharge from ICU
Time frame: through study completion,an average of 1 year
Determined by the number of days from admittance to discharge
Time frame: up to 1 year
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.
Time frame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
Peripheral blood CRP
Time frame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
cytokines IL-6
Time frame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
procalcitonin was measured at preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
Contact information is provided by the study sponsor or research team.
Chunling Jiang, PhD
CONTACT
Qian Li, PhD
CONTACT
Chunling Jiang
Other
Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis Undergoing Open Necrosectomy
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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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