Clinical trial NCT01590550: Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis
Official title: A Prospective Study of Citrate Based Dialysate in Pediatric Patients Receiving Intermittent Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Dialysis
Keywords: Pediatric hemodialysis
Anticoagulation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted pediatric patients

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Dialyzer Clotting Rate
timeFrame: Followed until HD with Citrate dialysate is discontinued, average 3 weeks
Secondary outcomes:
measure: Saline Flush Rate
timeFrame: Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeks
measure: Heparin Use Rate
timeFrame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Children's Hospital
state: California
Study officials:
affiliation: Loma Linda University
name: Rita D Sheth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.