Randomised, long-term administration of pH-neutral peritoneal dialysis solutions containing lactate (BALANCE) or bicarbonate (BICAVERA) in children
| ISRCTN | ISRCTN81137991 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81137991 |
| Protocol serial number | N/A |
| Sponsor | Fresenius Medical Care Deutschland GmbH (Germany) |
| Funder | Fresenius Medical Care (Germany) |
- Submission date
- 21/04/2004
- Registration date
- 24/05/2004
- Last edited
- 14/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University Children's Hospital Heidelberg, Pediatric Nephrology
INF 150
Heidelberg
69120
Germany
| Phone | +49-6221-5632396 |
|---|---|
| Franz_Schaefer@med.uni-heidelberg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | BIOKID |
| Study objectives | Peritoneal Dialysis (PD) is the preferred dialysis modality in children. Its major drawback is the limited technique survival due to infections and progressive ultrafiltration failure. Conventional PD solutions exert marked acute and chronic toxicity to local tissues. Prolonged exposure is associated with severe histopathological alterations including vasculopathy, neoangiogenesis, submesothelial fibrosis and a gradual loss of the mesothelial cell layer. Recently, more biocompatible PD solutions containing reduced amounts of toxic Glucose Degradation Products (GDPs) and buffered at neutral pH have been introduced into clinical practice. These solutions contain lactate, bicarbonate or a combination of both as buffer substance. Increasing evidence from clinical trials in adults and children suggests that the new PD fluids may allow for better long-term preservation of peritoneal morphology and function. However, the relative importance of the buffer in neutral-pH, low-GDP fluids is still unclear. In vitro, lactate is cytotoxic and vasoactive at the concentrations used in PD fluids. The BIOKID trial is designed to clarify the clinical significance of the buffer choice in biocompatible PD fluids. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | End stage renal disease |
| Intervention | Two months run-in period: standard PD solution After randomisation: ten months treatment with pH-neutral double-chambered PD solutions containing either lactate (one group) or bicarbonate (one group) Examinations: on clinical routine controls: blood tests, peritoneal equilibration tests, intraperitoneal pressure measurement. If abdominal surgery is indicated: peritoneal biopsy |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Peritoneal dialysis solutions containing lactate (BALANCE) or bicarbonate (BICAVERA) |
| Primary outcome measure(s) |
The primary outcome measure will be the longitudinal change in 4h-D/P creatinine in the sequential PET examinations. Differential changes in this parameter will indicate differences in the development of the peritoneal solute transport status over time. |
| Key secondary outcome measure(s) |
Secondary outcome measures will be surrogate parameters of mesothelial cell viability (CA-125), peritoneal neoangiogenesis (VEGF), fibrotic activity (TGF-beta) and local inflammation (Interleukin-6). With the same intention, the evolution of peritoneal histomorphology will be assessed in all patients available for sequential biopsies. Moreover, possible differential effects of lactate and bicarbonate buffer on the control of metabolic acidosis will be assessed by monthly blood gas analyses. Finally, the incidence and clinical course of peritonitis will be recorded as a possible indirect marker of local peritoneal macrophage function. |
| Completion date | 30/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 19 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 30/03/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/10/2004 | Yes | No |
