Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis

• Dialyzer clotting rate [ Time Frame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  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 based on clinical indications, upto a maximum period of 6 months
  
  

• Saline flush rate [ Time Frame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  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
  
  
• Heparin use rate [ Time Frame: Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  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
  
  

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