Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495859
Status:
UNKNOWN
Last Update Posted:
2008-04-04
First Post:
2007-07-02
Brief Title:
Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2008-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROUD
Brief Summary:
Patients with endstage liver disease characteristically are malnourished which is associated with poor outcome Formulas enriched with arginineω3 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None