Study on Omega-3 Fatty Acids for Reducing Organ Failure and Mortality in Patients with Severe Acute Pancreatitis

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What is this study about?

This clinical trial is focused on studying the effects of early treatment with omega-3 fatty acids in patients with severe acute pancreatitis. Severe acute pancreatitis is a condition where the pancreas becomes inflamed, leading to severe abdominal pain and potential complications like organ failure. The treatment being tested is called Omegaven, which is an emulsion for infusion containing omega-3 fatty acids derived from highly refined fish oil, along with glycerol and purified egg phospholipids. The purpose of the study is to see if early administration of these omega-3 fatty acids can reduce the risk of new organ failure and death in patients with this condition.

Participants in the study will receive either the omega-3 fatty acid infusion or standard medical care. The study will monitor the effects of the treatment over a period of time to determine if it helps in reducing complications associated with severe acute pancreatitis. The trial will also look at other factors such as the length of hospital stay, the need for additional medical interventions, and any side effects that may occur.

The study aims to provide valuable information on whether omega-3 fatty acids can be a beneficial addition to the treatment of severe acute pancreatitis, potentially improving outcomes for patients by reducing inflammation and supporting organ function. The results will be evaluated after a 180-day study period to assess the effectiveness of the treatment in preventing new organ failure and reducing mortality rates.

1 joining the study

Participation begins after meeting specific criteria, including a diagnosis of predicted severe acute pancreatitis (AP) within 24 hours, being at least 18 years old, and experiencing the first episode of AP.

The patient must be able to understand the study procedures and provide informed consent.

2 initial assessment

An initial assessment is conducted to confirm eligibility and establish baseline health status.

This includes evaluating the severity of AP using scores like APACHE-II and Modified Glasgow, and measuring CRP levels.

3 treatment administration

The treatment involves the early administration of Omega-3 fatty acids through an intravenous infusion.

The product used is called Omegaven, infusiooniemulsion, which contains glycerol, highly refined fish oil, and purified egg phospholipids.

4 monitoring and follow-up

The patient’s health is monitored throughout the study period, which lasts up to 180 days.

Regular assessments include checking for new organ failure, measuring CRP levels on specific days (0, 1, 2, 3, 5, and 7), and recording any adverse events or complications.

5 evaluation of outcomes

The primary outcome is a combination of new organ failure and mortality, evaluated after the 180-day period.

Secondary outcomes include individual components of the primary outcome, mortality rates, infectious complications, and the need for medical interventions.

6 completion of study

The study concludes with a final evaluation of the patient’s health status and the collection of data on hospital and ICU stay durations.

The study aims to determine the effectiveness of early Omega-3 fatty acid infusion in reducing organ failure and mortality in patients with severe AP.

Who Can Join the Study?

The patient must have a predicted severe acute pancreatitis. This means they have been diagnosed with acute pancreatitis and meet at least one of the following criteria within 24 hours:
- An APACHE-II score above 7. This is a scoring system used to measure the severity of illness in patients.
- A Modified Glasgow score above 2. This is another scoring system used to assess the severity of pancreatitis.
- A CRP-level above 150 mg per L. CRP stands for C-reactive protein, which is a marker of inflammation in the body.
The patient must be at least 18 years old.
This must be the first episode of acute pancreatitis for the patient.
The diagnosis of acute pancreatitis must have been made less than 24 hours ago.
The symptoms of acute pancreatitis must have started less than 72 hours ago.
The patient must be able to read and understand the study procedures.
The patient must be able to give informed consent, or their legal representatives must be able to do so.
Acute pancreatitis is defined by at least two of these three features:
- Upper abdominal pain.
- Serum lipase and/or amylase levels that are three times the upper level of normal. These are enzymes that help digest fats and sugars.
- Characteristic findings of acute pancreatitis on a special type of scan called a contrast-enhanced computed tomography (CECT) scan. However, this scan is usually not needed if the first two features are present.

Who Cannot Join the Study?

Patients who do not have a prediction of developing severe acute pancreatitis. This is a condition where the pancreas, an organ that helps with digestion, becomes very inflamed and can cause serious health problems.
Patients who are not within the specified age range for the study. The study is looking for participants who are adults.
Patients who are part of a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions.
Patients who are not able to receive Omega3 fatty acids through an intravenous method. This means getting the Omega3 directly into the bloodstream through a needle.
Patients who have any other medical conditions or factors that the study team believes would make it unsafe or inappropriate for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Bravis Ziekenhuis	Roosendaal	The Netherlands
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Ziekenhuis Gelderse Vallei Stichting	Ede	The Netherlands
Haga Hospital	Hague	The Netherlands
Meander Medical Center	Amersfoort	The Netherlands
Sint Franciscus Vlietland Groep Stichting	Rotterdam	The Netherlands
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Radboud universitair medisch centrum	Nijmegen	The Netherlands
Ajlrtafaa Ump	Amsterdam	The Netherlands
Ristqitow Zyudagoegx Sxcmddanc	Arnhem	The Netherlands
Hnqrbfjz Hlonelet	Hvidovre	Denmark
Edlzuyn Uehosjurgdvp Madmdzv Cdssoby Rlqbldiux (gvphnky Mhv	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	19.09.2023
The Netherlands	Recruiting	19.09.2023

Trial locations

Investigated drugs:

Omega-3 Fatty Acids are being studied for their potential benefits in patients with acute pancreatitis. The trial is investigating whether early intravenous administration of these fatty acids can reduce the risk of new organ failure and mortality. Omega-3 fatty acids are known for their anti-inflammatory properties, which may help in reducing inflammation and improving outcomes in patients with severe acute pancreatitis.

Investigated diseases:

Pancreatitis acute

Severe Acute Pancreatitis – Severe acute pancreatitis is a sudden inflammation of the pancreas that can lead to serious complications. It occurs when digestive enzymes become activated while still in the pancreas, causing damage to the tissue. This condition can result in systemic inflammation and may affect other organs, leading to organ failure. Symptoms often include severe abdominal pain, nausea, vomiting, and fever. The disease can progress rapidly, and complications such as infections or fluid collections around the pancreas may develop. Management typically focuses on supportive care and monitoring for complications.

Trial ID:

2023-505220-57-03

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Omega-3 Fatty Acids for Reducing Organ Failure and Mortality in Patients with Severe Acute Pancreatitis

What is this study about?

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