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
Secondary identifying numbers N/A
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Franz Schaefer
Scientific

University Children's Hospital Heidelberg, Pediatric Nephrology
INF 150
Heidelberg
69120
Germany

Phone +49-6221-5632396
Email Franz_Schaefer@med.uni-heidelberg.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymBIOKID
Study objectivesPeritoneal 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) studiedEnd stage renal disease
InterventionTwo 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Peritoneal dialysis solutions containing lactate (BALANCE) or bicarbonate (BICAVERA)
Primary outcome measureThe 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.
Secondary outcome measuresSecondary 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.
Overall study start date01/04/2003
Completion date30/03/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Month
Upper age limit19 Years
SexBoth
Target number of participants60
Key inclusion criteria60 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 criteria1. 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 enrolment01/04/2003
Date of final enrolment30/03/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

University Children's Hospital Heidelberg, Pediatric Nephrology
Heidelberg
69120
Germany

Sponsor information

Fresenius Medical Care Deutschland GmbH (Germany)
Industry

Else-Kröner-Strasse 1
Bad Homburg
61352
Germany

ROR logo "ROR" https://ror.org/04sk0bj73

Funders

Funder type

Industry

Fresenius Medical Care (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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