The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis
Kulcsszavak
Absztrakt
Leírás
The investigators will perform a randomized, double-blind, two-period crossover trial in chronic HD patients to compare the effect of citrasate dialysate (CD) and usual acetic-acid based dialysate (AD) on the cumulative intradialytic heparin dose. There is a four week run in phase followed by two weeks of intervention AD or CD followed by the remaining AD or CD intervention.
The primary outcome is change in intradialytic heparin dose achieved with citrasate compared with acetate dialysate. Secondary outcomes are the effect of CD compared with AD on systemic anticoagulation, bleeding time after HD, metabolic parameters, dialysis adequacy, inflammation, hemodynamic stability, and intra-rater and inter-rater reliability of the dialyzer clotting score.
Dátumok
| Utolsó ellenőrzés: | 02/28/2013 |
| Első benyújtás: | 10/10/2011 |
| Becsült beiratkozás benyújtva: | 11/06/2011 |
| Első közzététel: | 11/07/2011 |
| Utolsó frissítés beküldve: | 03/22/2013 |
| Utolsó frissítés közzétéve: | 03/25/2013 |
| A tanulmány tényleges kezdési dátuma: | 10/31/2011 |
| Becsült elsődleges befejezési dátum: | 12/31/2012 |
| A tanulmány becsült befejezési dátuma: | 12/31/2012 |
Állapot vagy betegség
Beavatkozás / kezelés
Other: CD - citrasate dialysate
Other: AD- acetic acid dialysate
Fázis
Karcsoportok
| Kar | Beavatkozás / kezelés |
|---|---|
| Active Comparator: AD- acetic acid dialysate AD is a standard bicarbonate based dialysate with a small amount of acetic acid which is the standard of care for dialysis. | Other: AD- acetic acid dialysate Acetate based dialysate; AD is the standard dialysate used in hemodialysis runs 4 hours three times weekly. For the study it will be used for a period of 2 weeks and compared to the CD study time period. |
| Experimental: CD - citrasate dialysate Dialysis with a citric acid based dialyasate. | Other: CD - citrasate dialysate Citrasate (CD) is substituted as the dialysate during the patients regular dialysis run 4hours three times weekly for a period of 2 weeks. The only difference between citrasate and the regular dialysate is the lack of acetic acid. |
Jogosultsági kritériumok
| Tanulásra alkalmas korok | 18 Years Nak nek 18 Years |
| Tanulásra alkalmas nemek | All |
| Egészséges önkénteseket fogad | Igen |
| Kritériumok | Inclusion Criteria: - chronic stable HD patients ≥ 18 years - on HD at least three times per week for at least 3 months Exclusion Criteria: - contraindication to heparin - currently using heparin-free HD - known clotting disorder - on warfarin therapy - dialyzing with a dysfunctional central venous catheter (blood flow rates consistently less than 300mL/min and/or frequent use of thrombolytic) - history of vascular access dysfunction - planned vascular access conversion or procedure during the study period - use of high calcium dialysate - active medical issue requiring hospitalization - planned kidney transplant during the study period - planned conversion of dialysis modality (peritoneal dialysis, nocturnal dialysis) during the study period - unable to provide informed consent |
Eredmény
Elsődleges eredménymérők
1. The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD [2 weeks after CD exposure, 2 weeks after AD exposure]
Másodlagos eredménymérők
1. The change from baseline in the number of bleeding events, and bleeding time after HD. [After 2 weeks of exposure to CD]
2. The change from baseline in the number of intradialytic hypotension episodes and the change from baseline in the QT interval [2 weeks after intervention exposure]
3. The change in small and middle solute clearance from baseline. [2 weeks post exposure]
4. The change from baseline on laboratory inflammatory markers as well as ionized calcium (iCa), magnesium (Mg), and bicarbonate (HCO3). [2 weeks post exposure]
5. The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score. [2 weeks]
