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ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients

NCT00396461 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2013-07-19

No results posted yet for this study

Summary

This study aims to analyse the effect of two total parenteral nutrition diets with lipid emulsions of different compositions on the incidence of nosocomial infection in critical patients. One diet will contain an MCT/LCT emulsion concentrated to 20% (50:50 ratio) and the other will comprise an MCT/LCT/fish oil emulsion (50:40:10 ratio). The secondary objective of this study is to analyse mortality in hospital and up to 6 months of discharge.

Conditions

  • Critical Illness

Interventions

DRUG

MCT/LCT (1:1)

Emulsion based on 20% MCT/LCT (50:50 ratio)

DRUG

MCT/LCT/omega-3 (5:4:1)

Emulsion based on 20% MCT/LCT/w3 (50:40:10 ratio), medium- and long-chain triglycerides and fish oil triglycerides.

Sponsors & Collaborators

  • B. Braun Medical SA

    lead INDUSTRY

Principal Investigators

  • Abelardo García de Lorenzo, MD · Hospital Universitario La Paz

  • Alfonso Bonet Saris, MD_Study Coordinator · University Hospital of Girona Dr. Josep Trueta

  • Teodoro Grau Carmona, MD_Study Coordinator · Hospital Severo Ochoa Leganés (Madrid)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-09-30
Completion
2011-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00396461 on ClinicalTrials.gov