Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation - Full Text View

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)

MedlinePlus related topics:

Dietary Supplements Liver Transplantation

Drug Information available for:

Arginine Arginine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by University of Heidelberg:

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
1: Active Comparator 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)
2: Active Comparator controls receive an isocaloric isonitrogenous non-specific nutritional support	Dietary Supplement: food for special medical purposes (FSMP) an isocaloric isonitrogenous non-specific nutritional support

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

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, Baden-Württemberg
	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

University of Heidelberg

Novartis

Investigators


Principal Investigator:	Peter Schemmer, MD	Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany

More Information

Main Study site This link exits the ClinicalTrials.gov site

Heidelberg University Hospital This link exits the ClinicalTrials.gov site

Learn more about the Department of Surgery at Ruprecht-Karls University of Heidelberg This link exits the ClinicalTrials.gov site

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

Keywords provided by University of Heidelberg:

Immunonutrition

immune enhancing diets

arginine

ω-3 fatty acids

nucleotides

liver transplantation

clinical trial

ClinicalTrials.gov processed this record on November 06, 2008

Sponsors and Collaborators:	University of Heidelberg Novartis
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00495859