Intradialytic Kinetics of Cardiac Biomarkers During Hemodialysis and Hemodiafiltration

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Device: High-flux hemodialysis; Device: Post-dilution hemodiafiltration

Detailed Description

Patients treated with maintenance hemodialysis:

Single-center, randomized, crossover study with 24 participants. The study will investigate the effect of high-flux HD (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.

On both trial days, the following dialysis settings will be the same for each individual patient:

• The dialysis sessions will last 4 hours.
• The same dialysis machine will be used, either the Fresenius Medical Care 5008 or 6008 CAREsystem machine.
• Same vascular access will be used.
• The composition of electrolytes in the dialysate will be the same.
• Blood flow rate will be >300 mL per minute and consistent.
• Dialysate flow rate will be 500 mL per minute.
• Ultrafiltration rate will be constant aiming at dry weight.
• Routine anticoagulation protocol will be unchanged, but consistent on both trial days.
• Routine dialysate temperature will be unchanged, but consistent on both trial days.

On both trial days, different baseline characteristics will be gathered, including demographic data, clinical data, dialysis characteristics, and routine blood samples. Blood samples, for the analysis of the selected cardiac biomarkers, will be collected:

• Before the dialysis session is started (baseline).
• After 10, 30, 60, 120, 180, and 240 minutes of dialysis. All samples will be collected from the blood dialyzer inlet; however, halfway into the dialysis session (after 120 minutes), samples will also be collected from the blood dialyzer outlet and from the dialysate.
• 30 minutes after dialysis cessation. However, if the patient will not stay 30 minutes, the post-dialysis sample will be gathered after 5 minutes.

Sub-study of patients treated with peritoneal dialysis:

In a sub-study, 24 patients treated with peritoneal dialysis, will be included for one or two venous blood samples (with a minimum of 1 week between) to determine the baseline concentration and week-to-week variation of the cardiac biomarkers of interest. On both trial days, different baseline characteristics will be gathered, including demographic data, clinical data, dialysis characteristics, and routine blood samples.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Department of Nephrology, Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

- Not able to understand or sign informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-flux hemodialysis then post-dilution hemodiafiltration; 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; FX CorDiax 100 dialyzer; Device: Post-dilution hemodiafiltration; FX CorDiax 1000 dialyzer
Experimental: Post-dilution hemodiafiltration then high-flux hemodialysis; 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; FX CorDiax 100 dialyzer; Device: Post-dilution hemodiafiltration; FX CorDiax 1000 dialyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dialyzer clearance of the cardiac biomarkers in high-flux hemodialysis and post-dilution hemodiafiltration.	Dialyzer clearance, calculated by dialysate and blood after 120 minutes of dialysis, of the cardiac biomarkers in high-flux hemodialysis and post-dilution hemodiafiltation. The two dialysis modalities will be compared.	After 120 minutes of dialysis.
Adherence of the cardiac biomarkers to the dialyzer membrane in high-flux hemodialysis and post-dilution hemodiafiltration.	Adherence of the cardiac biomarkers to the dialyzer membrane after 120 minutes of dialysis in high-flux hemodialysis and post-dilution hemodiafiltation. The two dialysis modalities will be compared.	After 120 minutes of dialysis.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Concentrations of the cardiac biomarkers in patients treated with hemodialysis and peritoneal 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.	Changes in plasma concentrations of the cardiac biomarkers at baseline on both intervention days.	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.	Concentrations of the cardiac biomarkers 5-30 minutes post-dialysis to investigate a potential rebound effect.	5-30 minutes after dialysis cessation.

Collaborators and Investigators

• Sponsor: Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Actual): April 10, 2025
• Study Completion (Actual): April 10, 2025

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Biomarkers; Natriuretic Peptide, Brain; Hemodialysis; Peritoneal Dialysis; Renal Replacement Therapy; Renal Dialysis; Troponin; Hemodiafiltration; Secretoneurin
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Cardiovascular Diseases
• Other Study ID Numbers: F2024-045 and N-20240016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No