End Stage Renal Disease
Conditions
Brief summary
The mortality rate in chronic hemodialysis (CHD) patients remains excessively high and approaches 21% per year. Among the many factors that adversely affects patient outcome is uremic malnutrition, a unique form of deranged nutritional status. It is associated with increased hospitalization and death risk in CHD patients. Several measures have been identified to prevent uremic malnutrition in CHD patients, including efforts to optimize dialysis regimen and dietary protein and energy intake. A large number of CHD patients suffer from uremic malnutrition in spite of these aggressive measures. The inevitable protein catabolic effects of the hemodialysis procedure are important factors leading to increased prevalence of uremic malnutrition. Preliminary data suggest that oral nutritional supplementation administered during the hemodialysis procedure counteracts these protein catabolic effects and leads to net protein anabolism in the acute setting. In this proposal, we hypothesize that Pro-Stat, a high nitrogen, enzyme-hydrolyzed, tryptophan-fortified, collagen protein supplement will reverse the net protein catabolism observed during hemodialysis procedure.
Interventions
DIETARY_SUPPLEMENTPro-Stat
two separate oral ingestions of nutrition supplement (either 30 ml per serving or at 60 ml per serving) during the hemodialysis session
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program. * Adequately dialyzed (Kt/V \> 1.2). * Age 18-75
Exclusion criteria
* Pregnant women. * Severe unstable underlying disease besides commonly associated with end stage renal disease. Cardiac patients that are stable will be included. * Patients hospitalized within the last month prior to the study. * Patients with malfunctioning arterial-venous access \[recirculation and/or blood flow \< 500 ml/min for an arterial-venous graft (AVG) or \<400 ml/min for an arterial-venous fistula (AVF)\] Patients receiving steroids and/or other immunosuppressive agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| net muscle protein balance | 10 hours |
Countries
United States
Outcome results
None listed