Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis

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

• Status: Completed
• Conditions: Complication of Dialysis
• Intervention / Treatment: Procedure: Use of citrate based dialysate

Detailed Description

All patients requiring inpatient hemodialysis will be screened for participation in the study based on inclusion and exclusion criteria as noted above. Informed consent for hemodialysis and for study participation will be obtained by the attending nephrologist prior to the start of the dialysis session. Patient specific hemodialysis orders will be placed by attending nephrology physician for each patient using a standardized hemodialysis order form. Citrasate® in standard concentration, with a standard blood flow of 600 -800 ml/min will be prescribed for all study patients, calcium and potassium contents of the dialysate will be determined by the attending pediatric nephrologist.

Monitoring: All patients will have routine monitoring as indicated for clinical care during each dialysis session.

Data Collection:Each treatment will be documented on a standardized hemodialysis run sheet. Data collection will be performed by any one of the researchers using a data collection sheet to ensure uniformity of data collection methods. Data to be collected includes patient demographics, admitting diagnosis, underlying renal disease, the presence of acute kidney injury versus chronic kidney disease, contraindications to heparin use and the presence of any bleeding diathesis. Dialysis specific data to be collected will include the site and type of dialysis access, dialysis prescription parameters and treatment duration. Lab data to be collected will include pre, post and intradialytic ionized calcium values, ACT values and pH and bicarbonate values. Data on the number of saline boluses required to maintain circuit patency, percent of prescribed blood flow achieved as well as any use of heparin will be collected.

Data Analysis will include

• T-test for comparison of changes in ionized calcium values, blood pH and bicarbonate values
• Percentage of patients with inadequate coagulation on citrate (ie. patients with grade III-IV streaking or required changing to heparin based dialysate)
• Percent of patients with any adverse events not accounted for during an routine dialysis session
• Cost analysis for the difference in costs using Citrasate® compared to a standard heparin based dialysis treatment

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Admitted pediatric patients

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single arm; Single arm for all patient receiving inpatient HD	Procedure: Use of citrate based dialysate; Use of heparin free citrate based dialysate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saline Flush Rate	Saline flush rate will be assesed as the percentage of hemodialysis treatments that require one or more saline flushes to maintain circuit patency from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months	Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeks
Heparin Use Rate	The heparin use rate will be assessed as the percentage of hemodialysis treatments that required additional use of heparin to maintain circuit patency. This will be assessed from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months	Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Rita D Sheth, MD, Loma Linda University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 29, 2012
• First Submitted That Met QC Criteria: May 1, 2012
• First Posted (Estimate): May 3, 2012

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Anticoagulation; Pediatric hemodialysis
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 5120017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Mean data will be presented