Efficiency and Biocompatibility in Hemodiafiltration Procedure

NCT06807905 | Completed Phase 4

• 1 other identifier: HDFCOMP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodiafiltration is a modern, increasingly used special hemodialysis method. Compared to hemodialysis, it allows greater clearance of medium- and high-molecular-weight molecules. Modern hemofiltration membranes are approaching the properties of the glomerular membrane in their properties. During hemodiafiltration, blood contact with the semipermeable membrane and blood lines causes activation of the coagulation system, so anticoagulation during the procedure is absolutely necessary. Heparin is routinely used as a method of anticoagulation in hemodiafiltration. Regional citrate anticoagulation is used primarily in patients with risk of bleeding. The purpose of our study is to evaluate the kinetics of citrate, calcium, and magnesium during hemodiafiltration and citrate anticoagulation, and in these way optimizing the citrate anticoagulation protocol during hemodiafiltration, and to compare the clearance of small and medium molecules between the two anticoagulations (citrate and heparin). The purpose of the study is also to compare biocompatibility parameters for heparin and citrate anticoagulation in hemodiafiltration.

Conditions

End Stage Renal Disease on Dialysis; Biocompatibility; Anticoagulation; Hemodiafiltration

Keywords

Dialysis; Hemodifiltraton; Biocompatibility; Anticoagulation; regional citrate anticoagulation; heparin

Outcome Measures

Primary Outcomes (1)

• removal of small and medium molecules

  The removal of small and medium molecules is different comparing citrate and heparin anticoagulation.

  during 4 hour dialysis

Secondary Outcomes (1)

• biocompatibility

  during 4 hour dialysis

Study Arms (2)

Heparin anticoagulation

ACTIVE COMPARATOR

Heparin anticoagulation in hemodiafiltration procedure

Drug: Heparin anticoagulation

Citrate anticoagulation

EXPERIMENTAL

Hemodiafiltration will be performed with regional citrate anticoagulation

Drug: Citrate anticoagulation

Interventions

Heparin anticoagulation DRUG

Hemodiafiltration will be performed with heparine anticoagulation

Heparin anticoagulation

Citrate anticoagulation DRUG

Patient will perform dialysis with citrate anticoagulation

Citrate anticoagulation

Eligibility Criteria

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

You may qualify if:

• CKD on dialysis

You may not qualify if:

• AKI on dialysis
• patients on anticoagulant therapy
• systemic bacterial infection

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

Location

Study Officials

• Milena Andonova, MD

  University Medical Centre Ljubljana, Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: February 4, 2025
• Study Start: February 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: February 1, 2021
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

SL (1)