ISRCTN91106416进行中（未招募）未知
Early on-demand drainage versus standard management among acute necrotizing pancreatitis patients complicated by persistent organ failure: an open-label multicenter randomized controlled trial
Department of science and technology of Jiangsu province0 个研究点目标入组 120 人开始时间: 2019年10月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 18/06/2020:
- •1. Aged 18 to 70 years
- •2. Able to provide informed consent
- •3. Confirmed diagnosis of AP
- •4. CT diagnosis of acute necrotic collection (ANC)
- •5. Technically able to be drained percutaneously, by ultrasound or CT guidance
- •6. Confirmed persistent organ failure (either respiratory, renal and/or cardiovascular lasting for more than 48 hours) that had not resolved by Day 7
- •7. During Day 8-Day 21, one or more of these criteria:
- •7.1. New-onset organ failure not present on Day 7 (no alleviation within 24 hours)
- •7.2. Organ failure (either single or multiple, modified Marshall score or SOFA score=2) persist
- •for seven natural days from Day 1
- •7.3. Aggravation of organ failure from that on Day 7 evidenced by increased modified Marshall
- •score or SOFA score (no alleviation within 24 hours)
- •Previous inclusion criteria:
- •Inclusion criteria for the screening period
- •Screening period starts from day 8 and extends to the end of the third week (day 21) consisting of 14 days:
- •1. Symptoms and signs of acute pancreatitis based on abdominal pain suggestive of AP, serum amylase at least three times the upper limit of normal, and/or characteristic findings of AP on computed tomography
- •2. Necrotic collection with available routes for ultrasound or CT guided percutaneous no matter sterile or infected
- •3. Confirmed persistent organ failure (either respiratory, renal or cardiovascular lasting for more than 48 hours), the organ failure score at day7 will be set as the baseline for the screening period
- •4. Age between 18 to 70 years old
- •Inclusion Criteria for randomization during screening period:
- •1. Patients in the screening period
- •2. Signs of deterioration from the baseline during the screening period including:
- •2.1. New-onset organ failure (no alleviation within 24 hours)
- •2.2. Unalleviated organ failure (either single or multiple, modified Marshall score=2) lasting for at least seven days including the duration before the screening period
- •2.3. Aggravation of organ failure from the baseline (either single or multiple) evidence by increased modified Marshall score (no alleviation within 24 hours)
排除标准
- •Current exclusion criteria as of 18/06/2020:
- •1. Pregnant pancreatitis
- •2. Chronic pancreatitis
- •3. Pancreatic tumor-related pancreatitis
- •4. Percutaneous or transluminal drainage or surgery is undertaken before admission
- •5. Patients had a history of cardio-pulmonary resuscitation during this episode
- •6. Patients with a known history of severe cardiovascular, respiratory, renal or hepatic disease defined as (1) greater than New York Heart Association class II heart failure, (2) active myocardial ischemia or (3) cardiovascular intervention within previous 60 days, (4) history of cirrhosis or (5) chronic kidney disease with creatinine clearance< 40 mL/min, or (6) chronic obstructive pulmonary disease with requirement for home oxygen
- •Previous exclusion criteria:
- •1. Pregnant
- •2. Chronic pancreatitis, recurrent acute pancreatitis or pancreatic tumor-related pancreatitis
- •3. Percutaneous or transluminal drainage or surgery undertaken before admission
- •4. Previous history of cardio-pulmonary resuscitation
- •5. History of severe cardiovascular, respiratory, renal, hepatic, hematologic, or immunologic disease defined as:
- •5.1. Greater than New York Heart Association class II heart failure
- •5.2. Active myocardial ischemia
- •5.3. Cardiovascular intervention within the previous 60 days
- •5.4. History of cirrhosis
- •5.5 Chronic kidney disease with creatinine clearance< 40 mL/min
- •5.6 Chronic obstructive pulmonary disease with requirement for home oxygen
研究者
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