Clinical trial NCT01376817: Comparative Study About the Impact of Two Oil Emulsions Administered Intravenously on Severe Acute Pancreatitis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Severe Acute Pancreatitis
Keywords: Severe acute pancreatitis
total parenteral nutrition
fat emulsions
omega 3 fatty acids
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory markers
timeFrame: Day 10
Secondary outcomes:
measure: Evolution of the degree of severity of acute severe pancreatitis
timeFrame: During the first 72 hours after admission
measure: Complications of acute severe pancreatitis
timeFrame: Day 10.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Daniel Cardona Pera, Doctor
role: PRINCIPAL_INVESTIGATOR
References: