Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Coagulation
  • Hemodialysis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This single centre, randomized cross-over study includes ten consecutive stable chronic hemodialysis (HD) patients who experienced stable dialysis sessions during the last 4 weeks, and had no known coagulation disorder, active inflammation or malignancy. Double-needle vascular access is achieved thr...

This single centre, randomized cross-over study includes ten consecutive stable chronic hemodialysis (HD) patients who experienced stable dialysis sessions during the last 4 weeks, and had no known coagulation disorder, active inflammation or malignancy. Double-needle vascular access is achieved through a native arterio-venous fistula or a well-functioning double lumen tunnelled central venous catheter. Patients are followed during 6 consecutive midweek dialysis sessions. At midweek, patients receive only 1/4th of their regular brand of Low-Molecular Weight Heparin anticoagulation at the beginning of the dialysis session. All test sessions are performed with blood flow at 300mL/min and dialysate flow at 500mL/min in post dilution hemodiafiltration (HDF) mode (substitution flow 75mL/min). Ultrafiltration rates are set according to the patient's interdialytic weight gain and clinical status. Patients are randomized for hemodialyzer type and dialysis duration: ATA™ Solacea 19H - 60min dialysis ATA™ Solacea 19H - 120min dialysis ATA™ Solacea 19H - 240min dialysis polysulfone FX800Cordiax - 60min dialysis polysulfone FX800Cordiax - 120min dialysis polysulfone FX800Cordiax - 240min dialysis Just before the termination of the 6 experimental midweek sessions, blood is sampled from the inlet and outlet blood lines. Blood samples are immediately centrifuged and serum vials are stored at -80°C until batch analysis. Post dialysis, dialyzers are rinsed and dried and scanned with micro computed tomography (CT) to count the number of open fibers.

Tracking Information

NCT #
NCT04746391
Collaborators
University Ghent
Investigators
Principal Investigator: Wim Van Biesen University Hospital, Ghent