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Pancreatitis and early omega-3-fatty acid infusion for reduction of organ failure and mortality.
EU CTIS ID: 2023-505220-57-03
What this study is testing
Overall study hypothesis Based on the literature, there seems to be a relation in AP between (hyper)inflammation, SIRS, new onset of organ failure and mortality. Omega3 fatty acids seem to have clinical beneficial effects through immunomodulation, supported by the decreased inflammatory biomarkers in patients with AP. Therefore, the following hypothesis was formulated: Early intravenous administration of Omega3 fatty acids reduces the composite endpoint of new onset organ failure and/or mortality in patients with predicted SAP. Overall study objective To investigate whether early intravenous administration of Omega3 fatty acids compared to standard medical care has beneficial effects and reduces the combined endpoint of new onset organ failure and/or mortality in patients with predicted SAP. Objectives randomized controlled trial Secondary aims in this study are to investigate the effect of Omega3 fatty acids supplementation on i.e. the separate endpoints of the combined endpoint, (serious) adverse events, hospital and ICU stay, need for interventions, hospital costs, and quality of life.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.