Endstage Renal Disease Clinical Trial
Official title:
Randomized, Multicenter Cross-over Study in Investigating the Effect of Bicarbonate-based Solutions (Physioneal 35 vs. 40) on Protein Metabolism in Children and Adolescents on Chronic Peritoneal Dialysis
The purpose of this study is to demonstrate an increase in protein metabolism during treatment with Physioneal 35® (containing lactate 10 mmol/l, calcium 1.75 mmol/l) compared to treatment with Physioneal 40® (containing lactate 15 mmol/l, calcium 1.25 mmol/l) in children and adolescents with end stage renal failure receiving peritoneal dialysis.
- Fat oxidation (13C-enrichment in expiration breath samples for U-C13-algae turnover)
- Growth markers (plasma levels of IgF-1, IgF-BP3, leptin)
- Biochemical markers of anabolism (plasma levels of total protein, albumin, transferrin)
- Serum thyroid function (fT3, fT4, TSH)
- Serum lipid status
- Serum markers of calcium/phosphate metabolism (PTH, calcium, ionized calcium,
phosphate, alkaline phosphatase)
- Prevalence of metabolic acidosis/ alkalosis (venous sample), serum lactate
- Safety parameters (such as normalized weekly Kt/v, parameters of glucose metabolism,
parameters of hepatic function, parameters of calcium-phosphate-metabolism, physical
examination incl. standing height, weight, assessment of complications related to
peritoneal dialysis as peritonitis, exit infections and inguinal hernia)
- Body composition (lean body mass and body fat mass/fluid)
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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