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

Newly Registered Patients for Primary Liver Transplantation Clinical Trial

— PROUD  

Official title:

Randomized Controlled Double Blind Multi-Center Clinical Trial to Assess the Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00495859
• Other study ID #: PROUD
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2007
• Last updated: April 2, 2008
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: April 2008
• Source: Heidelberg University
• Contact: Peter Schemmer, MD
• Phone: 004962215636500
• Email: peter.schemmer[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

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, ?-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Newly Registered Patients for Primary Liver Transplantation

Intervention

Dietary Supplement:
• Immunonutrition
food for special medical purpose (FSMP)
• food for special medical purposes (FSMP)
an isocaloric isonitrogenous non-specific nutritional support

Locations

Country	Name	City	State
Germany	Department of Surgery, Ruprecht-Karls University	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	enhanced anabolic recovery after transplantation as shown by reduced post-transplant morbidities and mortalities		the first 12 posttransplant weeks	Yes

External Links

•   Heidelberg University Hospital
•   Learn more about the Department of Surgery at Ruprecht-Karls University of Heidelberg