CITrate and Evodial for Effective Dialysis (CITED) Study

Chronic Kidney Disease Clinical Trial

— CITED  

Official title:

CITrate and Evodial for Effective Dialysis (CITED) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281045
• Other study ID #: S55895
• Status: Completed
• Phase: N/A
• First received: October 22, 2014
• Last updated: May 12, 2016
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

It is not known whether the combination of a heparin-grafted membrane plus citrate-containing dialysate is a valid alternative to regional citrate anticoagulation. This is a cross-over non-inferiority trial comparing these two anticoagulation strategies

Description:

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 In several countries, UFH has gradually been replaced by low molecular weight heparins (LMWH).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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged over 18 years,

• hemodynamic stability,

• hemoglobin 9 - 12 g/dl.

Exclusion Criteria:

• Any hemostatic disorder favoring either bleeding or clotting,

• anti-vitamin K treatment,

• risk of bleeding according to the criteria of Swartz (12).

Treatment with aspirin, dipyridamole or any drugs likely to interfere with platelet aggregation will be registered carefully, but will not be an exclusion criterion.

All vascular access types (AV-fistula, AV graft, catheter) are allowed. However, only patients with double route vascular access ('bipuncture') will be included in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• EVODIAL dialyzer and Selectbag citrate
Evodial is a trademark of Hospal-Gambro.
• Regional citrate anticoagulation
Regional citrate anticoagulation is performed according to local practice, using a calcium-containing dialysate

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven	Vlaams-Brabant
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of hemodialysis circuit	Completion of 4h dialysis session without circuit clotting that requires early treatment interruption	20 weeks	No
Secondary	Clotting of dialyser after the rinse	scored semi-quantitatively on a visual scale (0: no clotting; 1: mild clotting; 2: severe clotting, 4: completely clotted).	20 weeks	No