Intradialytic Kinetics of Cardiac Biomarkers During Hemodialysis and Hemodiafiltration
NCT Number: NCT06526702
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: End Stage Renal Disease on Dialysis
Interventions: DEVICE: High-flux hemodialysis|DEVICE: Post-dilution hemodiafiltration
Sponsor: Aalborg University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2026-08-31

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.

Primary Outcome Measures: 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: 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: 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.