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Hemodialysis Adequacy Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate (EvoCit-HD)

Primary Purpose

Kidney Diseases, Hemodialysis Complication, End Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

EvoCit

EvoHep

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring dialysis adequacy, clotting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UZ Brussel
CHU Brugmann

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

"EvoCit"

"EvoHep"

Arm Description

Standardized hemodialysis treatments 3x4hours/week. Intervention: "EvoCit procedure" using a heparin-grafted AN69ST dialyzer in combination with a citric acid enriched dialysate without any systemic anticoagulation.

Control: "EvoHep procedure" using a heparin-grafted AN69ST dialyzer in combination with a conventional bicarbonate-based dialysate and standardized systemic anticoagulation using unfractionated heparin.

Outcomes

Primary Outcome Measures

change in dialysis adequacy

spKt/Vurea

Secondary Outcome Measures

proportion of thrombotic dysfunction

premature termination of the dialysis session

change in dialysis adequacy expressed by middle molecule (MM) clearance

MM clearances

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

change in membrane coagulation

total cell volume measurement of the dialyzer after hemodialysis

occurence of biological evaluation of coagulation activation

TAT, PF1+2,

Full Information

NCT ID

NCT03887468

First Posted

January 22, 2019

Last Updated

January 15, 2020

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT03887468

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

May 15, 2018 (Actual)

Primary Completion Date

December 4, 2019 (Actual)

Study Completion Date

December 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Diseases, Hemodialysis Complication, End Stage Renal Disease

Keywords

dialysis adequacy, clotting

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

"EvoCit"

Arm Type

Active Comparator

Arm Description

Arm Title

"EvoHep"

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

EvoCit

Intervention Description

hemodialysis using the combination of the Evodial dialyzer with a citrate enriched dialysate

Intervention Type

Device

Intervention Name(s)

EvoHep

Intervention Description

hemodialysis using the combination of the Evodial dialyzer with a conventional bicarbonate based dialysate and systemic anticoagulation using unfractionated heparin

Primary Outcome Measure Information:

Title

change in dialysis adequacy

Description

spKt/Vurea

Time Frame

every midweek dialysis session through study duration, ie 2x4 weeks

Secondary Outcome Measure Information:

Title

proportion of thrombotic dysfunction

Description

premature termination of the dialysis session

Time Frame

every HD session through study duration, ie 2x4 weeks

Title

change in dialysis adequacy expressed by middle molecule (MM) clearance

Description

MM clearances

Time Frame

every 1st and 4th week HD session through study duration, ie 2x4 weeks

Title

occurence of complete circuit thrombosis

Description

rapidly occurring thrombosis of the extracorporeal circuit, which does not allow complete retransfusion of the blood circuit even if prescribed treatment duration is reached

Time Frame

every HD session through study duration, ie 2x4 weeks

Title

change in membrane coagulation

Description

total cell volume measurement of the dialyzer after hemodialysis

Time Frame

every midweek HD session through study duration, ie 2x4 weeks

Title

occurence of biological evaluation of coagulation activation

Description

TAT, PF1+2,

Time Frame

every 1st and 4th week HD session through study duration, ie 2x4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 use of urokinase the 2 months before study inclusion, including to restore catheter permeability. non-tunneled hemodialysis catheter use. known AV access outflow tract stenosis. planned vascular access intervention. 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

Facility Information:

Facility Name

UZ Brussel

City

Jette

ZIP/Postal Code

1090

Country

Belgium

Facility Name

CHU Brugmann

City

Laeken

ZIP/Postal Code

1020

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33940113

Citation

Francois K, De Clerck D, Tonnelier A, Cambier ML, Orlando C, Jochmans K, Cools W, Wissing KM. Dialyzer Performance During Hemodialysis Without Systemic Anticoagulation Using a Heparin-Grafted Dialyzer Combined With a Citrate-Enriched Dialysate: Results of the Randomized Crossover Noninferiority EvoCit Study. Am J Kidney Dis. 2022 Jan;79(1):79-87.e1. doi: 10.1053/j.ajkd.2021.04.004. Epub 2021 Apr 30.

Results Reference

derived

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

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