NL-OMON51853招募中3 期
Pancreatitis and early omega-3-fatty acid infusion for reduction of organ failure and mortality: a multicenter randomized controlled trial (PLANCTON) - PLANCTON trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 212
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 99（—）
入选标准
- •Predicted severe acute pancreatitis
- •>=18 years old
- •First episode of acute pancreatitis
- •<24 hours after diagnosis of acute pancreatitis
- •<72 hours after onset of symptoms of acute pancreatitis
- •Able to read and/or understand the study procedures
- •Able to give informed consent (or their legal representatives)
排除标准
- •Intake of any OM-3 FAs-, krill and/or algae supplements in the week prior to
- •Participation in another intervention study for AP
- •Organ failure on admission (Modified Marshall score >2)
- •Recurrent pancreatitis
- •Chronic pancreatitis
- •o Defined by the MANNHEIM criteria53
- •Known allergy to fish oil, seafood, soja or egg products
- •History or existing hyperlipidemia (laboratory proven triglycerides > 10.0
- •History of (severe) liver failure
- •Impaired lipid metabolism may lead to accumulation of fatty acids in the
- •blood, increasing risk of adverse events.
- •o Based on coagulation Factor V level or INR > 3
- •(without anti-coagulation by vitamine K)
- •Ketoacidosis
- •Acute thrombo-embolic disease
- •Pregnancy or lactation
- •Recent (< 6 months) myocardial infarction or strokeKnown coagulations
- •(e.g. Factor V Leiden, thrombocytopenia, etc.)
- •Pancreatitis due to a (suspected) periampullary/ampullary or bile duct
- •Other known or suspected malignancy that may interfere with the outcome(s)
- •and/or execution of the PLANCTON trial
- •Post ERCP-pancreatitis due to a (suspected) malignancy
- •Patient is classified as moribund or expected to die within 24hours
- •o The intervention will not be able to affect this patient and is therefore
- •useless to expose these patients.
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