End-Stage Renal Disease
Conditions
Keywords
end-stage renal disease, chronic kidney disease
Brief summary
End-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic changes or both. Human immunodeficiency virus-infection may exacerbate the state of malnutrition. In a pilot study, we recruit both HIV invected and non-infected patients on hemodialysis. Non-HIV patients will be randomized to peroral supplemental nutrition or no peroral supplemental nutrition. All HIV patients will receive peroral supplemental nutrition. The nutritional state will be determined in magnet resonance tomography at the start and at the end of the study (muscle diameter of triceps m.) and with laboratory parameters (plasma albumin and others). The hypothesis is that supplemental peroral nutrition (a total 250 kcal per day) will stop loss of muscle mass in end-stage renal disease patients (compared to their counterparts without supplemental peroral nutrition) as well as in the high risk group of HIV patients. This pilot study may lead to larger randomized clinical trials and, may affect dietary recommendations.
Detailed description
In end-stage renal disease (ESRD), cachexia is a common finding. Metabolic changes, malnutrition, or both appear to be the underlying problems. In fact, lean body mass per body weight better predicts prognosis than creatinin based models (NDT, 2004.19:1182). In addition, comorbidity such as HIV infection may exacerbate cachexia found in ESRD. Whether or not daily supplemental, high-caloric nutrition in ESRD corrects a catabolic state in ESRD is unclear. Hypothesis to be tested: Daily supplemental high-caloric nutrition beneficially affects cytokine stimulation (TNF alpha, IL 1beta, IL 6, CrP) and nutritional state (cross sectional area of triceps m. in mid-humerus position (MRT), plasma albumin) in in HIV-positive hemodialysis patients and in chronic hemodialysis patients compared to chronic hemodialysis patients without supplemental nutrition.
Interventions
DIETARY_SUPPLEMENTperoral high-caloric supplemental nutrition
HIV-positive hemodialysis patients will be given daily supplemental nutrition (125 ml, 2 kcal/ml) on top of recommended high-protein, high-caloric regular diet
DIETARY_SUPPLEMENTperoral supplemental nutrition
Chronic hemodialysis patients will be given daily peroral supplemental nutrition (125 ml/d, 2 kcal/ml) on top of their recommended high-protein, high caloric diet
Sponsors
Pfrimmer Nutricia GmbH, Erlangen , Germany
Johann Wolfgang Goethe University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients on hemodialysis for more than 1 year, * Group 1: HIV infection
Exclusion criteria
* patients on hemodialysis for less than 1 year, * Group 2 and 3: HIV infection * no pre-/post dialysis weight differences of \> 3 kg after long HD free interval over last 10 HD sessions. * no current high-caloric nutrition supplements or planned high-caloric supplements for clinical reasons. * pregnancy * for women: no use of oral contraceptives or other at least equally effective contraception in women with childbearing potential * known neoplastic disease other than skin tumors (except melanoma) * mental disease or retardation with impaired judgement power
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cross sectional area of triceps m. in mid-humerus position (MRT) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| plasma albumin < 3.6 mg/dl | 6 months |
Countries
Germany
Outcome results
None listed