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

Not Applicable

• Conditions: Newly Registered Patients for Primary Liver Transplantation
• Interventions: Dietary Supplement: Immunonutrition; Dietary Supplement: food for special medical purposes (FSMP)

• Registration Number: NCT00495859
• Lead Sponsor: Heidelberg University

Brief 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.

Detailed Description

Background. Patients with end stage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides, "immunonutrients", potentially improve their nutritional status. This study is designed to evaluate the clinical outcome of long-term "immunonutrition" of patients with end-stage liver disease while on the waiting list for liver transplantation.

Methods / design. A randomized controlled double blind multi-center clinical trial with two parallel groups comprising a total of 142 newly registered patients for primary liver transplantation has been designed to assess the safety and efficacy of the long-term administration of ORAL IMPACT®, an "immunonutrient" formula, while waiting for a graft. Patients will be enrolled the day of registration on the waiting list for liver transplantation. Study ends on the day of transplantation. Primary endpoints include patients' nutritional and physiological status, as measured by mid-arm muscle area, triceps skin fold thickness, grip strength, and fatigue score, as well as patients' health related quality of life. Furthermore, patients will be followed for 12 postoperative weeks to evaluate anabolic recovery after transplantation as shown by reduced post-transplant mechanical ventilation, hospital stay, wound healing, infectious morbidities (pneumonia, intra-abdominal abscess, sepsis, line sepsis, wound infection, and urinary tract infection), acute and chronic rejection, and mortality.

Discussion. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides have been proven to be beneficial in reducing postoperative infectious complications and length of hospital stay among the patients undergoing elective gastrointestinal surgery. Possible mechanisms include downregulation of the inflammatory responses to surgery and immune modulation rather than a sole nutritional effect.

Study Timeline

• Study First Submitted: 2007-07-02
• Study First Submitted QC: 2007-07-02
• Study First Posted: 2007-07-03
• Status Verified: 2008-04
• Study Start: 2008-04
• Last Update Submitted: 2008-04-02
• Last Update Posted: 2008-04-04
• Primary Completion: 2011-04
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Men and women between 18 and 68 years of age
• Scheduled for first liver transplantation
• Written informed consent
• Protein-calorie malnutrition: Mid-arm muscle area (MAMA) <85% standard

Exclusion Criteria

• Patients < 18 and > 68 years
• Pregnant or nursing women
• History of hypersensitivity to arginine, ω-3 fatty acids, or nucleotides
• Inability to take oral nutrition
• Patients with fulminant or subacute hepatic failure requiring urgent transplantation
• Mental condition rendering the subject incapable to understand the nature, scope, and consequences of the trial
• Simultaneous participation in another clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Immunonutrition	Study group will receive formula enriched with arginine, ω-3 fatty acids, and nucleotides once daily
2	food for special medical purposes (FSMP)	controls receive an isocaloric isonitrogenous non-specific nutritional support

Primary Outcome Measures

Name	Time	Method
improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life.	while in the waiting list for liver transplantation

Secondary Outcome Measures

Name	Time	Method
enhanced anabolic recovery after transplantation as shown by reduced post-transplant morbidities and mortalities	the first 12 posttransplant weeks

Trial Locations

Locations (1)

Department of Surgery, Ruprecht-Karls University; 🇩🇪 Heidelberg, Baden-Württemberg, Germany