Pancreatitis and early omega-3-fatty acid infusion for reduction of organ failure and mortality: a multicenter randomized controlled trial (PLANCTON trial)
Predicted severe acute pancreatitis
Participants are randomised to one of two groups using an online tool. Intervention: Intravenous administration of a lipid emulsion (0.2 g/kg/day) with OM-3 FAs, started within 24 hours of diagnosis of predicted SAP and within 72 hours after onset of symptoms of AP, for a total of 7 days. Control: Standard medical care
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)
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