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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-12-31

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.

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Detailed Description

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Information recorded in other data elements.

Conditions

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Severe Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Omega 3

Group Type EXPERIMENTAL

Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids

Intervention Type DRUG

40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10

MCT / LCT

Group Type ACTIVE_COMPARATOR

Fat emulsion with MCT and LCT

Intervention Type DRUG

40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10

Interventions

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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

Intervention Type 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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No