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Observational Study of Citrate Based Dialysis in Pediatric Patients Receiving Hemodialysis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Rita Sheth, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01590550
First received: April 29, 2012
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition
Complication of Dialysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study of Citrate Based Dialysate in Pediatric Patients Receiving Intermittent Hemodialysis

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Admitted pediatric patients

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590550

Locations
United States, California
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Rita D Sheth, MD Loma Linda University