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NCT01590550 · ClinicalTrials.gov registry record
Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis
A clinical trial, sponsored by Loma Linda University.
- Completed
- Registry status
- 18
- Enrollment target
NCT01590550: Completed study, sponsored by Loma Linda University.
NCT01590550 is a clinical trial that has completed, run by Loma Linda University. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01590550 has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- 18 participants
- Enrollment target
Study Summary
Providing hemodialysis requires the use of an extracorporeal circuit which must be anticoagulated. Inadequate anticoagulation can result in the dialyzer clotting with decreased circuit blood flows, inefficient dialysis and even significant blood loss secondary to circuit clotting.Heparin has been traditional agent used to provide anticoagulation. Heparin has multiple adverse side effects that would be best avoided in acutely ill patients who are at risk for bleeding. Alternative means of providing anticoagulation include citrate based anticoagulation. Citrasate® is a heparin free anticoagulant alternative that has been FDA approved since 1999 and readily available for commercial use since 2001. Citrasate® utilizes citric acid instead of acetic acid for acidification; the presence of small amounts of citrate in the dialysate also provides the means for anticoagulation. The concentration of citrate is low (2.4meq/L) and thus has a minimal effect on serum calcium values. No calcium monitoring or infusion is indicated. The purpose of this study is to obtain further data on the use of Citrasate® in admitted pediatric patients who receive hemodialysis as part of their therapy for acute kidney injury.
Primary Outcome
Dialyzer clotting rate will be assessed as the percent of hemodialysis treatments that developed a clot in the dialyzer from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued.
Interventions
- PROCEDURE Use of citrate based dialysate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-08 |
What the finished NCT01590550 record still lists
NCT01590550 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Use of citrate based dialysate is the first listed.
NCT01590550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01590550 about?
NCT01590550 is a clinical study titled "Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis". Providing hemodialysis requires the use of an extracorporeal circuit which must be anticoagulated. Inadequate anticoagulation can result in the dialyzer clotting with decreased circuit blood flows, inefficient dialysis and even significant blood loss secondary to circuit clotting.Heparin has been tr...
What is the current status of trial NCT01590550?
This trial is currently completed. The enrollment target is 18 participants. The study started on 2012-05. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01590550?
The interventions under investigation include: Use of citrate based dialysate (PROCEDURE).
Who is sponsoring clinical trial NCT01590550?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
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