CITrate and Evodial for Effective Dialysis (CITED) Study (CITED)
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|ClinicalTrials.gov Identifier: NCT02281045|
Recruitment Status : Completed
First Posted : November 3, 2014
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Device: EVODIAL dialyzer and Selectbag citrate Device: Regional citrate anticoagulation||Not Applicable|
Anticoagulation is one of the supporting pillars of chronic hemodialysis (HD) (1). The optimal anticoagulant regimen provides full anticoagulation of the extracorporeal circuit with minimal systemic effects and comes at an affordable cost. Unfractionated heparin (UFH) has been the standard of care for many years. In several countries, UFH has gradually been replaced by low molecular weight heparins (LMWH). LMWH are easy to use as they can be administered as a bolus injection and reduce membrane fibrin and platelet deposition (2,1). Both UFH or LMWH provide adequate anticoagulation of the extracorporeal circuit, at the price of systemic anticoagulation. Apart from bleeding, the administration of unfractionated heparins has also been associated with dyslipidemia, hypoaldosteronism and hyperkalemia, thrombopenia, osteoporosis, pruritus, and hypersensitivity reactions.
Several alternative anticoagulation regimens have been proposed including heparin coating of the dialyzer membrane and regional citrate anticoagulation. Regional citrate anticoagulation is performed by infusing citrate into the arterial line of the dialysis tubing to reduce ionized calcium concentrations to very low levels (4,1). Ionized calcium concentrations are restored by calcium supplementation prior to reinfusion of the blood into the patient. Most often, calcium repletion is by calcium infusion into the venous line. Alternatively, a conventional calcium containing dialysate will restore calcium concentrations and, although the anticoagulant effect is blunted in the venous line, gives acceptable results (5). A previous study suggested that regional citrate anticoagulation is superior to heparin-coated polyacrylonitrile dialyzers (AN69ST; Nephral 300ST, Gambro) and resulted in in significantly greater instantaneous urea nitrogen clearances (3).
While generally safe and adequate, regional citrate anticoagulation requires additional actions during preparatory phase (preparation of citrate and calcium infusion pumps) as well as during the treatment (measurement of ionized calcium). These additional actions result in additional costs.
Recently, acetate-free citrate-containing dialysate concentrates were introduced into clinical practice. Besides the advantages of acetate-free dialysate, this provides a modest local anticoagulant effect inside the dialyzer. Citrate-containing dialysate allowed to reduce heparin dose while maintaining extracorporeal circuit patency and dialyzer clearances (6).
The investigators questioned whether combination of citrate-containing dialysate and heparin-coated dialyzer membranes is equally effective as conventional regional citrate anticoagulation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||CITrate and Evodial for Effective Dialysis (CITED) Study|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: EVODIAL dialyzer and Selectbag citrate
Intervention for anticoagulation during dialysis: Combination of Heparin-coated AN69ST membrane (EVODIAL, Gambro-Hospal, Meyzieu, France) and citrate-containing dialysate (Selectbag citrate, Gambro, Lund, Sweden).
Device: EVODIAL dialyzer and Selectbag citrate
Evodial is a trademark of Hospal-Gambro.
Active Comparator: Regional citrate anticoagulation
Regional citrate anticoagulation, using a hypertonic sterile solution of trisodium citrate dihydrate (1.035 Mol/L, Baxter, Lessines, Belgium), infused into the afferent blood line. Citrate will be infused at a rate of 62.1 mM/h (60 mL/h). The anticoagulant effect of citrate will be neutralized using calcium containing dialysate (Ca 1.50 mmol/L). Dialysate sodium content will be set at 135 mEQ/L, and bicarbonate will be reduced to 25 mEq/L.
Device: Regional citrate anticoagulation
Regional citrate anticoagulation is performed according to local practice, using a calcium-containing dialysate
- Patency of hemodialysis circuit [ Time Frame: 20 weeks ]Completion of 4h dialysis session without circuit clotting that requires early treatment interruption
- Clotting of dialyser after the rinse [ Time Frame: 20 weeks ]scored semi-quantitatively on a visual scale (0: no clotting; 1: mild clotting; 2: severe clotting, 4: completely clotted).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281045
|Universitaire Ziekenhuizen Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|University Hospitals Leuven|
|Leuven, Belgium, 3000|
|Principal Investigator:||Björn Meijers, MD, PhD||UZ Leuven|