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Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation (PROUD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00495859
First received: July 2, 2007
Last updated: April 2, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention
Newly Registered Patients for Primary Liver Transplantation
Dietary Supplement: Immunonutrition
Dietary Supplement: food for special medical purposes (FSMP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

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 ]

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 ]

Estimated Enrollment: 156
Study Start Date: April 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Study group will receive formula enriched with arginine, ω-3 fatty acids, and nucleotides once daily
Dietary Supplement: Immunonutrition
food for special medical purpose (FSMP)
Other Name: ORAL IMPACT®
Active Comparator: 2
controls receive an isocaloric isonitrogenous non-specific nutritional support
Dietary Supplement: food for special medical purposes (FSMP)
an isocaloric isonitrogenous non-specific nutritional support
Other Name: IMPACT-Control Supplement

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.

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495859

Contacts
Contact: Peter Schemmer, MD 004962215636500 peter.schemmer@med.uni-heidelberg.de
Contact: Arash Nickkholgh, MD 004962215638584 arash.nickkholgh@med.uni-heidelberg.de

Locations
Germany
Department of Surgery, Ruprecht-Karls University Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Peter Schemmer, MD    +4962215636500    peter.schemmer@med.uni-heidelberg.de   
Contact: Arash Nickkholgh, MD    +4962215638584    arash.nickkholgh@med.uni-heidelberg.de   
Principal Investigator: Peter Schemmer, MD         
Sub-Investigator: Arash Nickkholgh, MD         
Sponsors and Collaborators
Heidelberg University
Novartis
Investigators
Principal Investigator: Peter Schemmer, MD Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Peter Schemmer, MD, Dept. of surgery, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00495859     History of Changes
Other Study ID Numbers: PROUD
Study First Received: July 2, 2007
Last Updated: April 2, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
Immunonutrition
immune enhancing diets
arginine
ω-3 fatty acids
nucleotides
liver transplantation
clinical trial

ClinicalTrials.gov processed this record on November 20, 2014