Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis
Completed
Conditions studied: Complication of Dialysis
In brief
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.
Key facts
- Study ID
- NCT01590550
- Run by
- Loma Linda University
- People needed
- 18
- Starts
- 2012-05-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2020-11-10
Who can join
Age: 0 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All pediatric patients between the ages of 0-21 years in the inpatient setting requiring hemodialysis for renal replacement therapy. These will include both patients with chronic renal failure and acute kidney injury, or any patient requiring dialysis as determined by an attending nephrologist.
You may not qualify if…
- Symptomatic hypocalcemia that is refractory to treatment 24 hours prior to the start of each dialysis session
- Known liver disorder/acute liver failure with an inability to metabolize citrate.
Where it is running
- Loma Linda University Children's Hospital — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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