NCT00776191

Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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)

Conditions

• Endstage Renal Disease

Interventions

Type	Name	Description
DRUG	Physioneal 35	Physioneal 35® for eight weeks, followed by Physioneal 40® for eight weeks
DRUG	Physioneal 40	Physioneal 40® for eight weeks followed by Physioneal 35® for eight weeks

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2008-10-21
• Last updated: 2015-06-04

Locations

5 sites across 1 country: Germany