Randomised controlled trial on the effects of parenteral fish oil emulsion in patients with severe acute pancreatitis - Effects of fish oil emulsion on severe acute pancreatitis patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018660-16-GB

Enrollment

Registered

2010-03-18

Start date

2010-04-22

Completion date

Unknown

Last updated

2020-06-22

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

Conditions

Acute Pancreatitis

Interventions

Trade Name: Lipidem 200mg/ml Product Name: Lipidem 200mg/ml Pharmaceutical Form: Emulsion for infusion Trade Name: Lipofundin MCT/LCT 20% Product Name: Lipofundin MCT/LCT 20% Pharmaceutical Form: Int

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All conscious patients between age of 18-85 admitted to the Leicester General hospital with severe acute pancreatitis proven by: a) compatible clinical features (abdominal pain with or without vomiting); b) associated with elevated serum amylase levels (>or=to 3 times the normal values) i,e >900 iu/l); and c) one of the severity criteria as outlined in the Atlanata severity criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The following will be excluded from the study: • Patients unconscious or unable to consent for themselves. • Patients below the age of 18 or above 85 years old. • Hypersensitivity to fish, egg or soy protein or other active substances of the TPN. • Uncontrolled hyperlipidaemia • Severe primary blood coagulation disorder • Acute pancreatitis accompanied with hyperlipidaemia • Ketoacidosis • Acute thromboembolic disease • Severe liver failure • Acute phase of myocardial infarction or stroke • Pregnancy and lactation • Severe renal failure without access to haemofiltration or dialysis (all patients with renal failure in Leicester General Hospital will have access to haemofiltration or dialysis if clinically indicated and needed)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of parenteral Omega 3 fish oil emulsion on the C-reactive protein (a sensitive marker in inflammation).;Secondary Objective: 1) Compare the severity scoring system for pancreatitis (Modified Early Warning score, APACHE II score, Glasgow prognostic score (Imrie), Ranson score, Systemic Inflammatory Response Syndrome (SIRS) and Sequential Organ Failure Assessment (SOFA) Score) and the speed of recovery for patients with severe inflammation of the pancreas given lipid infusion containing Omega 3 and a control group with same condition given lipid infusion without Omega 3. 2) Development of Local and/or Systemic complications according to Atlanta severity criteria for acute pancreatitis in study and control groups. 3) Progress in the inflammatory and anti-inflammatory mediators in study and control groups. 4) Progress of patients care, assess the duration of hospital stay and development of complications.;Primary end point(s): To monitor the progress in the C-reactive protein (sensitive marker in inflammation).	—

Measure

Time frame

Main Objective: To assess the effect of parenteral Omega 3 fish oil emulsion on the C-reactive protein (a sensitive marker in inflammation).;Secondary Objective: 1) Compare the severity scoring system for pancreatitis (Modified Early Warning score, APACHE II score, Glasgow prognostic score (Imrie), Ranson score, Systemic Inflammatory Response Syndrome (SIRS) and Sequential Organ Failure Assessment (SOFA) Score) and the speed of recovery for patients with severe inflammation of the pancreas given lipid infusion containing Omega 3 and a control group with same condition given lipid infusion without Omega 3. 2) Development of Local and/or Systemic complications according to Atlanta severity criteria for acute pancreatitis in study and control groups. 3) Progress in the inflammatory and anti-inflammatory mediators in study and control groups. 4) Progress of patients care, assess the duration of hospital stay and development of complications.;Primary end point(s): To monitor the progress in the C-reactive protein (sensitive marker in inflammation).

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Countries

United Kingdom

Outcome results

None listed

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