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Clinical Trials/NCT01376817
NCT01376817
Unknown
Phase 4

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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country60 target enrollmentStarted: July 2008Last updated:
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ConditionsSevere Acute Pancreatitis
InterventionsFat emulsion with MCT, LCT, olive oil and omega 3 fatty acidsFat emulsion with MCT and LCT
DrugsFat emulsion with MCT, LCT, olive oil and omega 3 fatty acidsFat emulsion with MCT and LCT

Overview

Phase
Phase 4
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
60
Locations
1
Primary Endpoint
Inflammatory markers
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Omega 3

Experimental

Intervention: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids (Drug)

MCT / LCT

Active Comparator

Intervention: Fat emulsion with MCT and LCT (Drug)

Outcomes

Primary Outcomes

Inflammatory markers

Time Frame: Day 10

LTB4, TXB2, PG2, IL-6, alfa-TNF, C-reactive protein (CRP) Day 1 (before treatment), 5 and 10

Secondary Outcomes

  • Evolution of the degree of severity of acute severe pancreatitis(During the first 72 hours after admission)
  • Complications of acute severe pancreatitis(Day 10.)

Investigators

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor Class
Other

Study Sites (1)

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