Newly Registered Patients for Primary Liver Transplantation Clinical Trial
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care