CTIS2024-511229-79-00进行中（未招募）1 期
ormal saline versus lactated Ringer’s solution for fluid administration in acute pancreatitis, an open-label multicenter randomized controlled trial: the WATERLAND trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 720
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •18 years of age, Diagnosis of acute pancreatitis according to the revision of the Atlanta classification (Banks et al, Gut 2013), which requires at least two of the following three criteria: A) typical abdominal pain, B) increase in serum amylase or lipase levels higher than three times the upper limit of normality, and C) signs of acute pancreatitis in imaging, Signature of informed consent
排除标准
- •New York Heart Association class II heart failure (slight limitation of physical activity; fatigue, palpitations, or dyspnea with ordinal physical activity) or worse, or ejection fraction <50% in the last echocardiography, Chronic pancreatitis defined by a Wirsung duct =4mm and/or pancreatic calcifications, More than 1 previous episode of acute pancreatitis (only 2 episodes of acute pancreatitis are allowed, one of them the present episode), Decompensated cirrhosis (Child’s class B or C), Hyper or hyponatremia (<135 or >145 mEq/L), Hyperkalemia (>5 mEq/L), Hypercalcemia (albumin or protein-corrected calcium >10.5 mg/dL or 2.62 mmol/L), Criteria for moderately severe or severe acute pancreatitis (revision of the Atlanta classification, Banks et al, Gut 2013) at recruitment: any of the following: A) presence of creatinine =1.9 mg/dL or =170 mmol/l, B) PaO2/FiO2=300, C) systolic blood pressure <90 mmHg despite initial fluid resuscitation, D) presence of local complications (acute peripancreatic fluid collections, acute necrotic collection, pseudocyst, walled-off necrosis, gastric outlet dysfunction, splenic or portal vein thrombosis, or colonic necrosis), E) exacerbation of previous comorbidity such as coronary artery disease or chronic lung disease, precipitated by the acute pancreatitis, Signs of volume overload or heart failure at recruitment (peripheral edema, pulmonary rales, or increased jugular ingurgitation at 45º), Time from pain onset to arrival to emergency room >24 h, Time from confirmation of pancreatitis to randomization >8 h
研究者
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