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

Heidelberg University

Status

Unknown

Conditions

Newly Registered Patients for Primary Liver Transplantation

Treatments

Dietary Supplement: Immunonutrition

Dietary Supplement: food for special medical purposes (FSMP)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00495859

PROUD

Details and patient eligibility

About

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.

Full 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.

Enrollment

156 estimated patients

Sex

All

Ages

18 to 68 years old

Volunteers

No Healthy Volunteers

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