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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Single arm for all patient receiving inpatient HD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of citrate based dialysate | Procedure | Use of heparin free citrate based dialysate |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Saline Flush Rate | 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 | Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Admitted pediatric patients
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| Name | Affiliation | Role |
|---|---|---|
| Rita D Sheth, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Children's Hospital | Loma Linda | California | 92350 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21040414 | Background | 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. | |
| 19379358 | 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. |
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Mean data will be presented
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Pediatric patients receiving hemodialysis (HD) at a single institution during the specified study period
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational | All patients receiving acute HD during the study period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational | All patients receiving acute HD during the study period |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 18 patients and 119 HD treatments | Posted | Number | percentage of total treatments | Followed until HD with Citrate dialysate is discontinued, average 3 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational | All patients receiving acute HD during the study period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clotting of circuit | General disorders | Systematic Assessment | Clotting of extracorporeal circuit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rita Sheth, MD | Loma Linda University | 909-558-8242 | rsheth@llu.edu |
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| Heparin Use Rate | 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 | Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued |
| 20615906 | 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. |
| 19265544 | 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. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Saline Flush Rate | 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 | Posted | Number | percentage of hemodialysis treatments | Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeks |
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| Secondary | Heparin Use Rate | 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 | Posted | Number | percentage of hemodialysis treatments | Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued |
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| 0 |
| 18 |
| 3 |
| 18 |
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