Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
NCT ID: NCT00495859
Last Updated: 2008-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
156 participants
INTERVENTIONAL
2008-04-30
2011-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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1
Study group will receive formula enriched with arginine, ω-3 fatty acids, and nucleotides once daily
Immunonutrition
food for special medical purpose (FSMP)
2
controls receive an isocaloric isonitrogenous non-specific nutritional support
food for special medical purposes (FSMP)
an isocaloric isonitrogenous non-specific nutritional support
Interventions
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Immunonutrition
food for special medical purpose (FSMP)
food for special medical purposes (FSMP)
an isocaloric isonitrogenous non-specific nutritional support
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for first liver transplantation
* Written informed consent
* Protein-calorie malnutrition: Mid-arm muscle area (MAMA) \<85% standard
Exclusion Criteria
* 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
18 Years
68 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Heidelberg University
OTHER
Responsible Party
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Dept. of surgery, University of Heidelberg
Principal Investigators
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Peter Schemmer, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany
Locations
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Department of Surgery, Ruprecht-Karls University
Heidelberg, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Peter Schemmer, MD
Role: primary
Arash Nickkholgh, MD
Role: backup
References
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Nickkholgh A, Schneider H, Encke J, Buchler MW, Schmidt J, Schemmer P. PROUD: effects of preoperative long-term immunonutrition in patients listed for liver transplantation. Trials. 2007 Aug 27;8:20. doi: 10.1186/1745-6215-8-20.
Related Links
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Main Study site
Heidelberg University Hospital
Learn more about the Department of Surgery at Ruprecht-Karls University of Heidelberg
Other Identifiers
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PROUD
Identifier Type: -
Identifier Source: org_study_id