Randomised, long-term administration of pH-neutral peritoneal dialysis solutions containing lactate (BALANCE) or bicarbonate (BICAVERA) in childre
Completed
- Conditions
- End stage renal diseaseUrological and Genital Diseases
- Registration Number
- ISRCTN81137991
- Lead Sponsor
- Fresenius Medical Care Deutschland GmbH (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
60 patients (European multicenter trial)
1. One month to 19 years
2. Continuous ambulatory peritoneal dialysis (CAPD) or continuous cycling peritoneal dialysis (CCPD)
3. Dwell volume 1100 ml/m^2 body surface area
4. Last peritonitis at least three weeks ago
5. Written informed consent
Exclusion Criteria
1. Reduced efficiency of peritoneal dialysis due to anatomic anomalies or intraperitoneal adhesions
2. Uncontrolled hyperphosphatemia
3. Severe pulmonary, cardiac, hepatic or systemic disease including any kind of malignancy
4. Current or recent (within 30 days) exposure to any investigational drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method