Inflammation of the pancreas
Conditions
Interventions
Intravenous administration of a lipid emulsion (0.2g/kg/day) with OM-3 FAs,
started within 24hrs of diagnosis of predicted SAP and within 72hrs after onset
of symptoms of AP, for a total of 7 days.
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Predicted severe acute pancreatitis • >=18 years old • First episode of acute pancreatitis •
Exclusion criteria
Exclusion criteria: • Intake of any OM-3 FAs-, krill and/or algae supplements in the week prior to complaints • 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 mmol/l) • 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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoints will be evaluated after the 180 days study period. The primary endpoint is a composite endpoint of new onset of organ failure (organ failure not present at randomization) and mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are individual components of the composite endpoint, severe complications (([infected] pancreas necrosis, sepsis, pneumonia or cholangitis), quality of life, costs effectiveness, number of (surgical, endoscopic or radiologic) interventions, length of hospital and ICU stay. | — |
Countries
Netherlands
Outcome results
None listed