Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526702
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Intradialytic Kinetics of Cardiac Biomarkers During Hemodialysis and Hemodiafiltration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intradialytic Kinetics of Cardiac Biomarkers During Hemodialysis and Hemodiafiltration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None