Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis

NCT01590550 | Completed Results

• 1 other identifier: 5120017
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric hemodialysis; Anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Single arm

Single arm for all patient receiving inpatient HD

Procedure: Use of citrate based dialysate

Interventions

Use of citrate based dialysate PROCEDURE

Use of heparin free citrate based dialysate

Single arm

Eligibility Criteria

• Age: 1 Day - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Admitted pediatric patients

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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Children's Hospital

Loma Linda, California, 92350, United States

Location

Related Publications (4)

• 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.

  PMID: 21040414 BACKGROUND

• 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.

  PMID: 19379358 BACKGROUND

• 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.

  PMID: 20615906 BACKGROUND

• 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.

  PMID: 19265544 BACKGROUND

Limitations and Caveats

No control group

Results Point of Contact

• Title: Rita Sheth, MD
• Organization: Loma Linda University

rsheth@llu.edu

909-558-8242

Study Officials

• Rita D Sheth, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Pediatrics

Study Record Dates

• First Submitted: April 29, 2012
• First Posted: May 3, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: August 1, 2015
• Last Updated: November 10, 2020
• Results First Posted: March 1, 2016

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)