Идёт набор NCT06380842

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

— Наблюдательное Necrotizing Pancreatitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Necrotizing Pancreatitis patients' organ dysfunction progression.
Кому может быть актуально: Состояния в реестре: Necrotizing Pancreatitis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

Другое Necrotizing Pancreatitis patients' organ dysfunction progression
Study the dynamic nature of organ dysfunction

Первичные конечные точки

Measure organ dysfunction change after open necrosectomy with respect to time [Срок оценки: up to postoperative day 7, or at hospital discharge, whichever comes first]

Вторичные конечные точки (11)

incidence of a composite of major complications [Срок оценки: up to postoperative day 28]
Incidence of ICU mortality [Срок оценки: through study completion, an average of 1year]
Incidence of hospital mortality [Срок оценки: through study completion, an average of 1 year]
Incidence of 28-day mortality [Срок оценки: through study completion, an average of 1 year]
Incidence of one year mortality [Срок оценки: through study completion, an average of 1 year]
ICU length of hospital stay [Срок оценки: through study completion, an average of 1 year]
Length of hospital stay [Срок оценки: through study completion，an average of 1 year]
The pancreatic symptoms score [Срок оценки: up to 1 year]
The levels of inflammatory factor CRP [Срок оценки: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.]
The levels of inflammatory cytokines IL-6 [Срок оценки: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.]
The levels of inflammatory procalcitonin [Срок оценки: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.]

Критерии участия

Критерии включения

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