Pancreatitis and early fishoil infusion for reduction of organ failure and mortality

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000474-26-NL

Enrollment

212

Registered

2022-03-29

Start date

2022-05-09

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Predicted severe acute pancreatitis

Interventions

Trade Name: Omegaven Product Name: Omegaven Product Code: DE/H/0139/001 Pharmaceutical Form: Emulsion for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Predicted severe acute pancreatitis • =18 years old • First episode of acute pancreatitis • =65 years) yes F.1.3.1 Number of subjects for this age range 212

Exclusion criteria

Exclusion criteria: • Intake of omega-3 fatty acids • Participation in another intervention study for acute pancreatitis • Organ failure on admission (Modified Marshall score >2) • Recurrent pancreatitis • Chronic pancreatitis o Defined by the MANNHEIM criteria • 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 o 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 (< 6 months) myocardial infarction or stroke • Known coagulations disorders (e.g. Factor V Leiden, thrombocytopenia, etc.) • Patient is classified as moribund or expected to die within 24hours o The intervention will not be able to affect this patient and is therefore useless to expose these patients.

Design outcomes

Primary

Measure	Time frame
Main Objective: The PLANCTON trial will investigate the effect of early intravenous omega-3 fatty acids on new onset organ failure and mortality in patients with predicted severe acute pancreatitis;Secondary Objective: 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.;Primary end point(s): The primary endpoint is a composite endpoint of new onset of organ failure (organ failure not present at randomization) and mortality.;Timepoint(s) of evaluation of this end point: from the moment of randomization untill 180 days afterwards	—

Measure

Time frame

Main Objective: The PLANCTON trial will investigate the effect of early intravenous omega-3 fatty acids on new onset organ failure and mortality in patients with predicted severe acute pancreatitis;Secondary Objective: 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.;Primary end point(s): The primary endpoint is a composite endpoint of new onset of organ failure (organ failure not present at randomization) and mortality.;Timepoint(s) of evaluation of this end point: from the moment of randomization untill 180 days afterwards

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Secondary

Measure	Time frame
Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: from the moment of randomization untill 180 days afterwards	—

Measure

Time frame

Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: from the moment of randomization untill 180 days afterwards

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Countries

Netherlands

Contacts

Public ContactDepartment of Surgery

Radboudumc

00310243617365

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026