EUCTR2019-000788-26-ES进行中（未招募）1 期
Effect of early weight-based aggressive versus non-aggressive goal-directed fluid resuscitation in the early phase of acute pancreatitis: an open-label multicenter randomized-controlled trial - Aggressive fluid resuscitation in the acute pancreatitis
Enrique de Madaria0 个研究点目标入组 700 人开始时间: 2019年4月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •adult (=18) patients with AP according to the revision of the Atlanta classification (RAC) (Banks et al, Gut 2013): at least 2 of the following 3 criteria: A) Typical abdominal pain, B) Increase in serum amylase or lypase levels higher than 3 times the upper limit of normality, and C) Signs of AP in imaging techniques (CT scan or MRI). This study requires signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •non-controlled arterial hypertension (>160 (Systolic BP) and/or 100 mmHg (diastolic BP), heart failure (New York Hear Association Class II-IV) or ejection fraction <50%, decompensated cirrhosis (Child’s Class B or C), Hyper or hyponatremia (<135 or >145 mEq/l), hyperpotassemia (>5 mEq/l), hypercalcemia (albumin or protein-corrected calcium>10.5 mg/dl), chronic kidney failure (basal glomerular filtration rate <60 mL/min/1.73m2), clinical signs of volume overload (peripheral edema, pulmonary rales, and ascites), organ failure according to the RAC (Marshall=2), time from pain onset to arrival to emergency room >24h, time from confirmation of pancreatitis to randomization >8h, severe comorbidity associated with an estimated life expectancy <1 year and confirmed chronic pancreatitis (in case of recurrent alcoholic pancreatitis a recent (<6 months) CT scan/MRI or endoscopic ultrasound is needed to rule out chronic pancreatitis).
研究者
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