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

Study Overview
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Brief Summary
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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
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Information recorded in other data elements.

Official Title
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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

Conditions
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Severe Acute Pancreatitis

Intervention / Treatment
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* Drug: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids
* Drug: Fat emulsion with MCT and LCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe acute pancreatitis, total parenteral nutrition, fat emulsions, omega 3 fatty acids