EUCTR2015-000829-37-NL进行中（未招募）1 期
Fluid hydration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis: the FLUYT-prevent trial. a multicenter randomized controlled superiority trial. - FLUYT-prevent trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 826
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
- 性别
- All
入选标准
- •Age between 17 and 86
- •written 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 750
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •1) Allergy to NSAID’s or other contraindications
- •2) Ongoing acute pancreatitis
- •3) Ongoing hypotension, including those with sepsis
- •4) Cardiac insufficiency (CI, >NYHA Class II heart failure)
- •5) Renal insufficiency (RI, creatinin clearance <40ml/min)
- •6) Active ulcer disease
- •7) Severe liver dysfunction: Liver cirrhosis and ascites
- •8) Respiratory insufficiency (pO2<60mmHg or 90% despite FiO2 of 30% or requiring mechanical ventilation).
- •9) Pregnancy
- •10) Hyponatremia (Na+ levels < 130mmol/l)
- •11) Hypernatremia (Na+ levels > 150mmol/l)
- •12) Oedema
- •13) Low risk of PEP: chronic calcific pancreatitis or pancreatic head mass or routine biliary stent exchange; re-ERCP with a history of endoscopic sphincterotomy with a CBD intervention (PD intervention is allowed)
- •14) Planned prophylactic pancreatic stent placement
研究者
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