Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis
Condition: Complication of Dialysis
Study type: Observational

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
    

Intervention name(s): Use of citrate based dialysate
Intervention type(s): Procedure
Intervention description(s): Use of heparin free citrate based dialysate
Intervention MeSH terms: Dialysis Solutions
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Admitted pediatric patients
      
Keywords: Pediatric hemodialysis; Anticoagulation