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

NCT03887468 | Completed

• 1 other identifier: UZB-NEF-2017-EvoCit-HD
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Diseases; Hemodialysis Complication; End Stage Renal Disease

Keywords

dialysis adequacy; clotting

Outcome Measures

Primary Outcomes (1)

• change in dialysis adequacy

  spKt/Vurea

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

Secondary Outcomes (5)

• proportion of thrombotic dysfunction

  every HD session through study duration, ie 2x4 weeks

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

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

• occurence of complete circuit thrombosis

  every HD session through study duration, ie 2x4 weeks

• change in membrane coagulation

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

• occurence of biological evaluation of coagulation activation

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

Study Arms (2)

"EvoCit"

ACTIVE COMPARATOR

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.

Device: EvoCit

"EvoHep"

ACTIVE COMPARATOR

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

Device: EvoHep

Interventions

EvoCit DEVICE

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

"EvoCit"

EvoHep DEVICE

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

"EvoHep"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Vascular access dysfunction defined as
• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (2)

UZ Brussel

Jette, 1090, Belgium

Location

CHU Brugmann

Laken, 1020, Belgium

Location

Related Publications (2)

• Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

  PMID: 38189593 DERIVED

• 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.

  PMID: 33940113 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic; Thrombosis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: March 25, 2019
• Study Start: May 15, 2018
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)