Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation (PROUD)
Randomized Controlled Double Blind Multi-Center Clinical Trial to Assess the Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germany, 69120
- Recruiting
- Department of Surgery, Ruprecht-Karls University
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Contact:
- Peter Schemmer, MD
- Phone Number: +4962215636500
- Email: peter.schemmer@med.uni-heidelberg.de
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Contact:
- Arash Nickkholgh, MD
- Phone Number: +4962215638584
- Email: arash.nickkholgh@med.uni-heidelberg.de
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Principal Investigator:
- Peter Schemmer, MD
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Sub-Investigator:
- Arash Nickkholgh, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Study group will receive formula enriched with arginine, ω-3 fatty acids, and nucleotides once daily
|
food for special medical purpose (FSMP)
Other Names:
|
|
Active Comparator: 2
controls receive an isocaloric isonitrogenous non-specific nutritional support
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an isocaloric isonitrogenous non-specific nutritional support
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life.
Time Frame: while in the waiting list for liver transplantation
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while in the waiting list for liver transplantation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
enhanced anabolic recovery after transplantation as shown by reduced post-transplant morbidities and mortalities
Time Frame: the first 12 posttransplant weeks
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the first 12 posttransplant weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Schemmer, MD, Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PROUD
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