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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Unknown status

CT.gov ID

NCT01376817

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Pancreatitis	Drug: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids Drug: Fat emulsion with MCT and LCT	Phase 4

Detailed Description

Information recorded in other data elements.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Official Title:

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

Study Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Jul 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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