Hemodialysis Adequacy Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate

End Stage Renal Disease Clinical Trial

— EvoCit-HD  

Official title:

Dialysis Adequacy and Clotting Complications During Anticoagulation-free Hemodialysis Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate: a Prospective Randomized Crossover Study. (EvoCit-HD Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887468
• Other study ID #: UZB-NEF-2017-EvoCit-HD
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: December 4, 2019

Study information

• Verified date: January 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After providing informed consent, patients will be randomized to either the intervention treatment ("EvoCit procedure") or the control treatment ("EvoHep procedure").

After randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. After the last dialysis treatment of the fourth treatment week and after a long interdialytic interval, patients will crossover to the alternative hemodialysis procedure. After crossover, the study will be completed with, again, four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients treated with hemodialysis or hemodiafiltration since at least three months.

• Hemodialysis or hemodiafiltration prescription of 3 x 4 hours weekly.

• = 18 years of age.

• Patients able and agree to provide signed informed consent.

Exclusion Criteria:

• Contraindication to heparin defined as known heparin-induced thrombopenia or active bleeding risk with contra-indication for systemic anticoagulation, categorized as defined by Swartz and Port1.

• Planned surgery during study period, including scheduled living-donor kidney transplantation during study period.

• Hypercoagulable state defined as known malignancy, known APC resistance/FV Leiden, known prothrombin gene mutation, known protein C or protein S deficiency, known antithrombin deficiency.

• Mean Qb of <300ml/min during one of the last 3 dialysis sessions before inclusion.

• 1 or more results of spKt/Vurea < 1,35 during the last three months prior to study inclusion.

• Need for 2 or more supplementary dialysis sessions on top of the regular 3x4 hours weekly hemodialysis regimen during the last month before inclusion.

• Vascular access dysfunction defined as

1. use of urokinase the 2 months before study inclusion, including to restore catheter permeability.

2. non-tunneled hemodialysis catheter use.

3. known AV access outflow tract stenosis.

4. planned vascular access intervention.

5. planned vascular access conversion.

• Known allergy against heparin grafted AN69STmembranes.

• Use of ACE-inhibitor

• Use of vitamin K antagonist

• Use of novel oral anticoagulant therapy.

• Any medical condition, which puts the patient at risk of premature study termination in the opinion of the investigator.

• Planned conversion of dialysis modality during study period or planned absence/leave (including pregnancy or planned pregnancy).

• Symptomatic hypocalcemia.

• Hb < 8g/dl at screening.

• Hct > 45% at screening.

• Perdialytic total parenteral nutrition therapy

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis Complication
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• EvoCit
hemodialysis using the combination of the Evodial dialyzer with a citrate enriched dialysate
• EvoHep
hemodialysis using the combination of the Evodial dialyzer with a conventional bicarbonate based dialysate and systemic anticoagulation using unfractionated heparin

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette
Belgium	CHU Brugmann	Laeken

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in dialysis adequacy	spKt/Vurea	every midweek dialysis session through study duration, ie 2x4 weeks
Secondary	proportion of thrombotic dysfunction	premature termination of the dialysis session	every HD session through study duration, ie 2x4 weeks
Secondary	change in dialysis adequacy expressed by middle molecule (MM) clearance	MM clearances	every 1st and 4th week HD session through study duration, ie 2x4 weeks
Secondary	occurence of complete circuit thrombosis	rapidly occurring thrombosis of the extracorporeal circuit, which does not allow complete retransfusion of the blood circuit even if prescribed treatment duration is reached	every HD session through study duration, ie 2x4 weeks
Secondary	change in membrane coagulation	total cell volume measurement of the dialyzer after hemodialysis	every midweek HD session through study duration, ie 2x4 weeks
Secondary	occurence of biological evaluation of coagulation activation	TAT, PF1+2,	every 1st and 4th week HD session through study duration, ie 2x4 weeks