Pancreatitis and early omega-3-fatty acid infusion for reduction of organ failure and mortality: a multicenter randomized controlled trial (PLANCTON).

Stichting Radboud University Medical Center0 个研究点目标入组 212 人开始时间: 2023年10月12日最近更新: 2024年8月21日

适应症

试验速览

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•Predicted severe AP (The diagnosis of acute pancreatitis and one or more of the following, within 24hrs: 1. APACHE-II score above 7 2. Modified Glasgow score above 2 3. CRP-level above 150 mg per L), minimum of 18 years old, First episode of AP, less than 24 hours after diagnosis of AP, less than 72 hours after onset of symptoms of AP, Able to read and or understand the study procedures, Able to give informed consent (or their legal representatives), Definitions: Acute pancreatitis: at least 2 of these 3 features11: 1. Upper abdominal pain 2. Serum lipase and or amylase levels 3 times the upper level of normal 3. Characteristic findings of AP on contrast enhanced computed tomography scan (CECT). Usually, no CECT imaging is needed as the diagnosis can be made with the findings under 1 and 2

•Intake of any omega3 fatty acids-, krill and or algae supplements in the week prior to complaints, Acute thrombo-embolic disease, Pregnancy or lactation, Recent (less than 6 months) myocardial infarction or stroke, Known coagulations disorders (e.g. Factor V Leiden, thrombocytopenia, etc.), Pancreatitis due to a (suspected) periampullary or ampullary or bile duct malignancy, 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 The intervention will not be able to affect this patient and is therefore useless to expose these patients., Participation in another intervention study for AP, Organ failure on admission (Modified Marshall score more than 2), Recurrent pancreatitis, Chronic pancreatitis (Defined by the MANNHEIM criteria), Known allergy to fish oil, seafood, soja or egg products, History or existing hyperlipidemia (laboratory proven triglycerides more than 10.0 mmol per litre), History of (severe) liver failure. (Impaired lipid metabolism may lead to accumulation of fatty acids in the blood, increasing risk of adverse events) Based on coagulation Factor V level or INR more than 3 (without anti-coagulation by vitamine K), Ketoacidosis

发起方

Stichting Radboud University Medical Center