ISRCTN13860158进行中（未招募）3 期
Pancreatitis and early omega-3-fatty acid infusion for reduction of organ failure and mortality: a multicenter randomized controlled trial (PLANCTON trial)
Radboud University Nijmegen Medical Centre0 个研究点目标入组 212 人开始时间: 2022年5月17日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- 性别
- All
入选标准
- •1. Predicted severe acute pancreatitis
- •2. =18 years old
- •3. First episode of acute pancreatitis
- •4. <24 hours after diagnosis of acute pancreatitis
- •5. <72 hours after onset of symptoms of acute pancreatitis
- •6. Able to read and/or understand the study procedures
- •7. Able to give informed consent (or their legal representatives)
排除标准
- •Current participant exclusion criteria as of 01/11/2023:
- •1. Intake of omega-3 fatty acids
- •2. Participation in another intervention study for acute pancreatitis
- •3. Organ failure on admission (Modified Marshall score >2)
- •4. Recurrent pancreatitis
- •5. Chronic pancreatitis. Defined by the MANNHEIM criteria
- •6. Known allergy to fish oil, seafood, soja, or egg products
- •7. History or existing hyperlipidemia (laboratory-proven triglycerides >10.0 mmol/l)
- •8. History of (severe) liver failure. Based on coagulation Factor V level or INR >3
- •9. (without anti-coagulation by vitamin K)
- •10. Ketoacidosis
- •11. Acute thrombo-embolic disease
- •12. Pregnancy or lactation
- •13. Recent (<6 months) myocardial infarction or stroke
- •14. Known coagulation disorders (e.g. Factor V Leiden, thrombocytopenia, etc.)
- •15. Pancreatitis due to a (suspected) periampullary/ampullary or bile duct malignancy
- •16. Other known or suspected malignancy that may interfere with the outcome(s) and/or
- •execution of the PLANCTON trial
- •17. Post ERCP-pancreatitis due to a (suspected) malignancy
- •18. Patient is classified as moribund or expected to die within 24 hours
- •Previous participant exclusion criteria:
- •1. Intake of omega-3 fatty acids
- •2. Participation in another intervention study for acute pancreatitis
- •3. Organ failure on admission (Modified Marshall score >2)
- •4. Recurrent pancreatitis
- •5. Chronic pancreatitis. Defined by the MANNHEIM criteria
- •6. Known allergy to fish oil, seafood, soja, or egg products
- •7. History or existing hyperlipidemia (laboratory-proven triglycerides >10.0 mmol/l)
- •8. History of (severe) liver failure. Based on coagulation Factor V level or INR >3
- •9. (without anti-coagulation by vitamin K)
- •10. Ketoacidosis
- •11. Acute thrombo-embolic disease
- •12. Pregnancy or lactation
- •13. Recent (<6 months) myocardial infarction or stroke
- •14. Known coagulation disorders (e.g. Factor V Leiden, thrombocytopenia, etc.)
- •15. Patient is classified as moribund or expected to die within 24 hours
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