NCT01590550|CompletedResults
Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis
A Prospective Study of Citrate Based Dialysate in Pediatric Patients Receiving Intermittent Hemodialysis
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Sponsor study identifier
observational
18
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)Study Completion
August 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2012
Actual (reported)May 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 3, 2012
Actual (reported)January 2014
Actual (reported)August 2015
Actual (reported)March 1, 2016
Actual (reported)Dialyzer Clotting Rate
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.
Followed until HD with Citrate dialysate is discontinued, average 3 weeks
Saline Flush Rate
Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeks
Heparin Use Rate
Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued
Single arm for all patient receiving inpatient HD
Use of heparin free citrate based dialysate
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Admitted pediatric patients
Loma Linda University Children's Hospital
Loma Linda, California, 92350, United States
Hanevold C, Lu S, Yonekawa K. Utility of citrate dialysate in management of acute kidney injury in children. Hemodial Int. 2010 Oct;14 Suppl 1:S2-6. doi: 10.1111/j.1542-4758.2010.00483.x.
Davenport A. Anticoagulation options for pediatric hemodialysis. Hemodial Int. 2003 Apr 1;7(2):168-76. doi: 10.1046/j.1492-7535.2003.00022.x.
Cheng YL, Yu AW, Tsang KY, Shah DH, Kjellstrand CM, Wong SM, Lau WY, Hau LM, Ing TS. Anticoagulation during haemodialysis using a citrate-enriched dialysate: a feasibility study. Nephrol Dial Transplant. 2011 Feb;26(2):641-6. doi: 10.1093/ndt/gfq396. Epub 2010 Jul 8.
No control group
Rita D Sheth, MD
Loma Linda University
18 participants (actual enrollment reported by the registry).
First Submitted
April 29, 2012
First Posted
May 3, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Gabutti L, Lucchini B, Marone C, Alberio L, Burnier M. Citrate- vs. acetate-based dialysate in bicarbonate haemodialysis: consequences on haemodynamics, coagulation, acid-base status, and electrolytes. BMC Nephrol. 2009 Mar 5;10:7. doi: 10.1186/1471-2369-10-7.
Primary Completion
January 2014
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
November 10, 2020
Results First Posted
March 1, 2016
Record last verified: 2020-10
Mean data will be presented
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Source: ClinicalTrials.gov.
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