An interventional study of High-flux hemodialysis and Post-dilution hemodiafiltration in End Stage Renal Disease on Dialysis, sponsored by Aalborg University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-07.
Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Diagnostic
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:
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.
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:
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:
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.
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This study's enrollment of 26 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
- Not able to understand or sign informed consent.
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
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
FX CorDiax 100 dialyzer
FX CorDiax 1000 dialyzer
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.
Time frame: 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.
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.
Time frame: 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.
Time frame: After 120 minutes of dialysis.
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.
Time frame: 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.
Time frame: 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.
Time frame: 5-30 minutes after dialysis cessation.
Plan to share: No
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Aalborg University Hospital