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Tracking Information | |||||||||
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First Received Date † | July 2, 2007 | ||||||||
Last Updated Date | April 2, 2008 | ||||||||
Start Date † | April 2008 | ||||||||
Current Primary Outcome Measures † |
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 ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00495859 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
enhanced anabolic recovery after transplantation as shown by reduced post-transplant morbidities and mortalities [ Time Frame: the first 12 posttransplant weeks ] [ Designated as safety issue: Yes ] | ||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation | ||||||||
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 | ||||||||
Brief 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. |
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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. |
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Study Phase | |||||||||
Study Type † | Interventional | ||||||||
Study Design † | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
Condition † | Newly Registered Patients for Primary Liver Transplantation | ||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 156 | ||||||||
Estimated Completion Date | April 2011 | ||||||||
Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years to 68 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | Germany | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00495859 | ||||||||
Responsible Party | Prof. Peter Schemmer, MD, Dept. of surgery, University of Heidelberg | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | University of Heidelberg | ||||||||
Collaborators †† | Novartis | ||||||||
Investigators † |
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Information Provided By | University of Heidelberg | ||||||||
Verification Date | April 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |