Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation

NCT00495859 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2008-04-04

No results posted yet for this study

Summary

Patients with endstage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine,ω3 fatty acids, and nucleotides potentially improve their nutritional status. This randomized placebo-controlled double blind multicenter clinical trial with longterm preoperative supplementation with such an enriched formula will evaluate evaluate effects of such formulas on patients' quality of life, survival, and posttransplant morbidities.

Conditions

  • Newly Registered Patients for Primary Liver Transplantation

Interventions

DIETARY_SUPPLEMENT

Immunonutrition

food for special medical purpose (FSMP)

DIETARY_SUPPLEMENT

food for special medical purposes (FSMP)

an isocaloric isonitrogenous non-specific nutritional support

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY
  • Heidelberg University

    lead OTHER

Principal Investigators

  • Peter Schemmer, MD · Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT00495859 on ClinicalTrials.gov