Intradialytic Kinetics of Cardiac Biomarkers During Hemodialysis and Hemodiafiltration

NCT06526702 | Completed

• 1 other identifier: F2024-045 and N-20240016
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, crossover study aims to investigate the intradialytic kinetics of selected cardiac biomarkers in patients with end-stage renal disease treated with dialysis. The cardiac biomarkers of interest include high-sensitivity cardiac troponin I, high-sensitivity cardiac troponin T, brain natriuretic peptide, and a novel cardiac biomarker named secretoneurin. In 24 patients treated with maintenance hemodialysis, the study will compare high-flux hemodialysis (HD) with post-dilution hemodiafiltration (HDF) to investigate:

• Baseline concentrations and week-to-week plasma variations of the cardiac biomarkers.
• Changes in the plasma concentrations of the cardiac biomarkers during high-flux HD and post-dilution HDF.
• Dialyzer clearance of the cardiac biomarkers in high-flux HD and post-dilution HDF.
• Adherence of the cardiac biomarkers to the dialyzer membrane.
• Concentrations of the cardiac biomarkers 30 minutes post-dialysis to investigate a potential rebound effect. Additionally, a sub-study of 24 patients treated with peritoneal dialysis will investigate the baseline concentrations and week-to-week plasma variations of the same cardiac biomarkers.

Conditions

End Stage Renal Disease on Dialysis

Keywords

Renal Dialysis; Hemodiafiltration; Hemodialysis; Peritoneal Dialysis; Renal Replacement Therapy; Troponin; Natriuretic Peptide, Brain; Secretoneurin; Biomarkers; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Changes in the cardiac biomarkers from baseline to during and after high-flux hemodialysis and post-dilution hemodiafiltration.

  Changes in the selected cardiac biomarkers from baseline, to after 10, 30, 60, 120, 180, and 240 minutes of dialysis, and 5-30 min. after dialysis cessation in both high-flux hemodialysis and post-dilution hemodiafiltration. The two dialysis modalities will be compared.

  Before the start of a dialysis session; after 10, 30, 60, 120, 180, and 240 minutes of dialysis; and 5-30 min. after dialysis cessation.

Secondary Outcomes (2)

• Dialyzer clearance of the cardiac biomarkers in high-flux hemodialysis and post-dilution hemodiafiltration.

  After 120 minutes of dialysis.

• Adherence of the cardiac biomarkers to the dialyzer membrane in high-flux hemodialysis and post-dilution hemodiafiltration.

  After 120 minutes of dialysis.

Other Outcomes (3)

• Baseline concentrations of the cardiac biomarkers high-sensitivity cardiac troponin I, high-sensitivity cardiac troponin T, brain natriuretic peptide, and secretoneurin in patients with end-stage renal disease treated with dialysis.

  Baseline.

• Week-to-week plasma variation of the cardiac biomarkers high-sensitivity cardiac troponin I, high-sensitivity cardiac troponin T, brain natriuretic peptide, and secretoneurin in patients with end-stage renal disease treated with dialysis.

  At baseline on two different days with a minimum of 1 week between.

• Concentrations of the cardiac biomarkers high-sensitivity cardiac troponin I, high-sensitivity cardiac troponin T, brain natriuretic peptide, and secretoneurin 5-30 minutes post-dialysis.

  5-30 minutes after dialysis cessation.

Study Arms (2)

High-flux hemodialysis then post-dilution hemodiafiltration

EXPERIMENTAL

Participants will first receive high-flux hemodialysis. Following a washout period of 1-3 weeks, they will receive post-dilution hemodiafiltration.

Device: High-flux hemodialysis; Device: Post-dilution hemodiafiltration

Post-dilution hemodiafiltration then high-flux hemodialysis

EXPERIMENTAL

Participants will first receive post-dilution hemodiafiltration. Following a washout period of 1-3 weeks, they will receive high-flux hemodialysis.

Device: High-flux hemodialysis; Device: Post-dilution hemodiafiltration

Interventions

High-flux hemodialysis DEVICE

FX CorDiax 100 dialyzer

High-flux hemodialysis then post-dilution hemodiafiltration; Post-dilution hemodiafiltration then high-flux hemodialysis

Post-dilution hemodiafiltration DEVICE

FX CorDiax 1000 dialyzer

High-flux hemodialysis then post-dilution hemodiafiltration; Post-dilution hemodiafiltration then high-flux hemodialysis

Eligibility Criteria

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

You may qualify if:

• Age of 18 years or older.
• Clinically stable patients with end-stage renal disease treated with maintenance hemodialysis or peritoneal dialysis.
• Regarding patients treated with hemodialysis: Dialysis access with an arteriovenous fistula and able to maintain a blood flow rate \>300 mL.

You may not qualify if:

• \- Not able to understand or sign informed consent.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Department of Nephrology, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

• Drivsholm CL, Nygaard L, Glerup RI, Birnum ATS, Jensen JD, Svensson M. Intradialytic kinetics of cardiac biomarkers during high-flux haemodialysis and postdilution haemodiafiltration: study protocol for a randomised crossover trial. BMJ Open. 2026 Jan 16;16(1):e105551. doi: 10.1136/bmjopen-2025-105551.

  PMID: 41545041 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor, and PhD student at the Department of Nephrology, Aalborg University Hospital, Denmark

Model Details: Single-center, randomized, crossover study with 24 participants. The study will investigate the effect of high-flux hemodialysis (using the FX CorDiax 100 dialyzer) and post-dilution HDF (using the FX CorDiax 1000 dialyzer) on the intradialytic kinetics of selected cardiac biomarkers. The study will not be blinded, but the order of the interventions will be randomized. The two dialysis sessions will be conducted on the same weekday. Between the two interventions, the patient will have a wash-out period of 1-3 weeks with standard dialysis treatment.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start: September 12, 2024
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)