Clinical trial NCT00776191: Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Endstage Renal Disease
Keywords: Physioneal 35
Physioneal 40
children
chronic peritoneal dialysis
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2008-10-21
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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)

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.

Primary outcomes:
measure: To demonstrate an increase in protein metabolism during treatment with Physioneal 35® compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis.
timeFrame: 16 weeks
Secondary outcomes:
measure: To demonstrate a improved Fat oxidation during treatment with Physioneal compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Pediatric Nephrology, Universiy Children's Hospital
city: Erlangen
country: Germany
facility: Dept. of Pediatric Nephrology, University Hospital Erlangen
city: Hannover
country: Germany
facility: Dept. of Pediatric Nephrology, University of Hannover
city: Memmingen
country: Germany
facility: Dept. of Nephrology, children´s hospital Memmingen
city: Rostock
country: Germany
facility: Dept. of Nephrology, University of Rostock
Study officials:
affiliation: University Hospital Erlangen, Department of Pediatrics University Hospital Koeln
name: Joerg Doetsch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: