randomized multicenter cross-over study to compare the effect of physioneal 35 to 40 on the protein metabolism

Conditions: Endstage Renal Disease

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.

* 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)

Eligibility criteria:
inclusion criteria: * patients who are males or non-pregnant females between the ages of 3 months and 18 years. * patients who are on regular automated peritoneal dialysis due to end stage renal failure for at least 3 months. * patients and/or their parents must be capable of understanding the purpose and risks of the study. * patients and/or their parents (or guardians) who are willing to give written informed consent and willing to participate in and comply with the study protocol. exclusion criteria: * use of pure lactate, amino acid or oligosaccharide solutions for peritoneal dialysis * peritonitis episode less than 6 weeks before enrolment * hypercalcemia (serum) \> 2.75 mmol/l in three independent measurements during 10 days * severe secondary hyperthyroidism (ipth \> 500 ng/l) * renal anemia with hemoglobin (blood) \< 10 mg/dl * impaired hepatic function (ast/sgot or alt/sgpt \> 2 times the upper limit of the reference range) * patients who are participating in another study that requires ethics committee approval. non-interventional studies are permitted. * pregnant female patients, females of childbearing potential who are unwilling or unable to use adequate contraception methods. * severe respiratory insufficiency * malnourishment (body weight \< -2.5 sds for height and gender) or severe deterioration of fat metabolism * patients with a history of malignancy of any organ system, treated or untreated * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the investigational product and the comparator, including * major deterioration of the abdominal wall (e.g. dermal infections or burns, hernia) * major deterioration of the abdominal cavity (e.g. ascites, ileus, adhesions, bowel perforation, defects of the diaphragm, tumours) * patients with a history of viral infections such as hiv or hepatitis b, c.

Keywords: physioneal 35 physioneal 40 children chronic peritoneal dialysis