Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Prote… (NCT00776191) | Clinical Trial Compass
TerminatedPhase 4
Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism
Stopped: al study sites stoped on 15/05/2012 because of insufficient recrutement.
Germany5 participantsStarted 2008-09
Plain-language 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.
Who can participate
Age range3 Months – 18 Years
SexALL
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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 al…
What they're measuring
1
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
Trial details
NCT IDNCT00776191
SponsorUniversity of Erlangen-Nürnberg Medical School