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

Phase 4

• Conditions: Severe Acute Pancreatitis
• Interventions: Drug: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids; Drug: Fat emulsion with MCT and LCT

• Registration Number: NCT01376817
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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.

Detailed Description

Information recorded in other data elements.

Study Timeline

• Study Start: 2008-07
• Status Verified: 2009-02
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Last Update Submitted: 2011-06-17
• Study First Posted: 2011-06-20
• Last Update Posted: 2011-06-20
• Primary Completion: 2011-07
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega 3	Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids	-
MCT / LCT	Fat emulsion with MCT and LCT	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evolution of the degree of severity of acute severe pancreatitis	During the first 72 hours after admission	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.
Complications of acute severe pancreatitis	Day 10.	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).

Trial Locations

Locations (1)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain