CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Use of citrate based dialysateprocedure
Likely dose
Not stated in record
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Search/NCT01590550
NCT01590550N/ACompleted

A Prospective Study of Citrate Based Dialysate in Pediatric Patients Receiving Intermittent Hemodialysis

Loma Linda University·observational·Posted May 3, 2012·Updated Nov 10, 2020

In Brief

An observational study evaluating Use of citrate based dialysate for Complication of Dialysis. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2012
Enrollment StartMay 1, 2012
Primary CompletionJan 1, 2014
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.2 years ago

Interventions

Use of citrate based dialysateprocedure

Use of heparin free citrate based dialysate