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Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis

NCT01590550 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2020-11-10

Study results available
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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.

Conditions

  • Complication of Dialysis

Interventions

PROCEDURE

Use of citrate based dialysate

Use of heparin free citrate based dialysate

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Rita D Sheth, MD · Loma Linda University

Eligibility

Min Age
1 Day
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-01-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01590550 on ClinicalTrials.gov