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

Severe Acute Pancreatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01376817
• Other study ID #: ELomega3
• Secondary ID: 2007-005611-26
• Status: Recruiting
• Phase: Phase 4
• First received: June 16, 2011
• Last updated: June 17, 2011
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2009
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Jordi Virgili Arumí
• Phone: 00-34-932919050
• Email: jvirgili[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

Description:

Information recorded in other data elements.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Pancreatitis
• Severe Acute Pancreatitis

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers	LTB4, TXB2, PG2, IL-6, alfa-TNF, C-reactive protein (CRP) Day 1 (before treatment), 5 and 10	Day 10	No
Secondary	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	No
Secondary	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.	No

External Links

•   Hospital de la Santa Creu i Sant Pau's website
•   Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau's website