Comparative Study About the Impact of Two Oil Emulsions Administered Intravenously on Severe Acute Pancreatitis

Comparative Study About the Impact of Two Oil Emulsions, One of Them Formulated With MCT, LCT, Olive Oil and Omega 3 Fatty Acids Versus Another One Formulated With MCT and LCT, Administered Intravenously on Severe Acute Pancreatitis Clinical Evolution

The purpose of this study is to comparatively assess the potential antiinflammatory effects of intravenous lipid emulsions rich in omega 3 polyunsaturated fatty acids and olive oil versus intravenous lipid emulsions made exclusively with MCT and LCT on the evolution of patients with severe acute pancreatitis during the period in needing artificial nutrition support with total parenteral nutrition so unique.

Study Overview

• Status: Unknown
• Conditions: Severe Acute Pancreatitis
• Intervention / Treatment: Drug: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids; Drug: Fat emulsion with MCT and LCT

Detailed Description

Information recorded in other data elements.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jordi Virgili Arumí; Phone Number: 9303 00-34-932919050; Email: jvirgili@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    • Contact: Jordi Virgili Arumí; Phone Number: 9303 00-34-932919050; Email: jvirgili@santpau.cat
    • Principal Investigator: Daniel Cardona Pera, Doctor
    • Sub-Investigator: Amelia Romero Merlos, Bachelor
    • Sub-Investigator: Juan María Sánchez Segura, Doctor
    • Sub-Investigator: Ferran Caballero Mestres, Doctor
    • Sub-Investigator: Manuel Rodríguez Blanco, Doctor
    • Sub-Investigator: Vicens Artigas Raventós, Doctor
    • Sub-Investigator: Josefina Muñoz Casadevall, Doctor
    • Sub-Investigator: Maria Antònia Mangues Bafalluy, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of acute pancreatitis: characteristic abdominal pain, serum amylase and / or lipase >= 3 times the upper limit of normal range, characteristic CT-scan
• Criteria of severity of acute pancreatitis diagnosed at <= 72 hours following admission: severity Index of Balthazar's CT-scan (with contrast) >= grade D, APACHE-II >= 8, C-reactive protein >= 150 mg/L
• Inability to initiate feeding (oral or with nutritional supplements) and / or enteral nutrition during the 5 days after the diagnosis and prediction of the indication of nil-by-mouth >= 5 days
• <= 3 mmol/L of triglycerides in the blood
• Men and women aged >= 18 years old
• Acceptance of informed consent

Exclusion Criteria:

• Known hipersensitivity to the fish, egg or soy proteins
• Lipid etiology
• > 3 mmol/L of triglycerides in the blood
• Severe hepatic impairment
• Severe renal insufficiency without dialysis or haemofiltration
• Serious disturbances of blood clotting
• Acute shock
• Infusion therapy general contraindications
• Clinical conditions of instability that must not be taken with parenteral nutrition
• Have other acute or chronic inflammatory diseases
• Status of severe immunosuppression: cytotoxic treatment in 15 days prior to inclusion and / or a disease that causes white blood cells levels <5000/mm3
• Treatment with steroids > 0.25 mg/kg/day of prednisone or equivalent doses of corticosteroids: as pre-treatment and / or during admission

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega 3	Drug: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids; 40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10
Active Comparator: MCT / LCT	Drug: Fat emulsion with MCT and LCT; 40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory markers	LTB4, TXB2, PG2, IL-6, alfa-TNF, C-reactive protein (CRP) Day 1 (before treatment), 5 and 10	Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the degree of severity of acute severe pancreatitis	At hospital admission: age, BMI, organ failure. Evolution of the degree of severity of acute severe pancreatitis: severity risk factors at the hospital admission (age, BMI, organ failure), pronostic signs of severity during the first 72 hours after admission : APACHE-II, Ranson criteria, serum hematocrit, CT-scan with Balthazar index, CRP. Day 10: CT-scan with Balthazar index, CRP.	During the first 72 hours after admission
Complications of acute severe pancreatitis	From day 1 to day 10. Complications of acute severe pancreatitis: local complications (necrosis, pseudocyst, abscess, surgery, ERCP), systemic complications (SIRS, sepsis, organ failure, other ones, mortality).	Day 10.

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Daniel Cardona Pera, Doctor, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

Helpful Links

• Hospital de la Santa Creu i Sant Pau's website

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: June 17, 2011
• First Posted (Estimate): June 20, 2011

Study Record Updates

• Last Update Posted (Estimate): June 20, 2011
• Last Update Submitted That Met QC Criteria: June 17, 2011
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: omega 3 fatty acids; Severe acute pancreatitis; total parenteral nutrition; fat emulsions
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: ELomega3; 2007-005611-26