| Trial ID: | L0624 |
| Source ID: | NCT01632046
|
| Associated Drug: |
Lactate And Bicarbonate Buffered Dialysis Solutions
|
| Title: |
Administration of pH-Neutral Peritoneal Dialysis Solutions Containing Lactate or Bicarbonate in Children
|
| Acronym: |
BIOKID
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Failure|Peritoneal Membrane Disorder
|
| Interventions: |
DRUG: lactate and bicarbonate buffered dialysis solutions
|
| Outcome Measures: |
Primary: Evaluation of the effect of a lactate based and a bicarbonate based double-chambered, pH-neutral PD solution on peritoneal transport capacity in children., Following a two months run in period patients are randomized to either lactate or bicarbonate buffered PD solution. The primary outcome measure is dialysate over plasma creatinine as a measure of peritoneral transport efficacy. It will be determined at 0, 3, 6 and 10 months., 2 months run in 10 months study period | Secondary: Ultrafiltration, The ultrafiltration is recorded daily by the caretakers, mean weakly ultrafiltration will be analysed. (Further outcome measures include the effect of either PD solution on acid-base balance, incidence and severity of peritonitis, and on surrogate parameters of biocompatibility and carbonyl stress)., 2 months run in 10 months observation
|
| Sponsor/Collaborators: |
Sponsor: Heidelberg University
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-03
|
| Completion Date: |
2007-03
|
| Results First Posted: |
|
| Last Update Posted: |
2012-06-29
|
| Locations: |
University Children's Hospital, Vienna, 1090, Austria|University Children's Hospital, Helsinki, 00029, Finland|University Children's Hospital, Strasbourg, 67098, France|University Children's Hospital, Essen, 45122, Germany|University Children´s Hospital, Hamburg, 20246, Germany|University Children's Hospital, Jena, 07740, Germany|University Children's Hospital, Milan, 20122, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT01632046
|
