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In this study, 24 prevalent hemodialysis patients will undergo four regular hemodialysis sessions during which four different treatments will be performed.
So far, there is no data on cardiac bioenzyme levels during hemodialysis on the MCO membrane, thus, a acute elevation during hemodialysis might be mitigated by increased clearance.
Patients who are on hemodialysis will be included in this study. After obtaining informed consent, patients will be treated with four different hemodialysis sessions:
Sequence 1: MCO, low flux, HDF, high flux Sequence 2: low flux, high flux, MCO, HDF Sequence 3: high flux, HDF, low flux, MCO Sequence 4: HDF, MCO, high flux, low flux Dialysis treatment will be standardized according to our clinic standard. Dialysis fluid temperature will be set to 1.0°C below the patient's body temperature, which will be assessed by auricular thermometers, to achieve maximal hemodynamic stability. Dialysis fluid composition will be standardized to calcium of 1.25mmol/L, bicarbonate of 30mmol/L, and a variable potassium and sodium concentration, depending on the patients' plasma potassium and sodium concentration.
Ultrafiltration volume will be set according to the caretaking provider.
Membranes used in the study will be FX CorDiax 10, 800 (Fresenius Medical Care, Bad Homburg vor der Höhe, Germany) and Theranova 400 (Baxter, Deerfield, Illinois, USA). We will perform the analysis only in mid-week dialysis due to the following reasons: First, hemodynamic stability is most often compromised during the first treatment of the week, due to the need of large volumes of ultrafiltration and, second, because we assume that troponin T levels reach a steady state 48 hours after the last dialysis session.
Patients undergo their routine dialysis schedule, only the membrane will be changed.
In each session, blood samples will be taken at the start of dialysis, after 1 and after 4 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCO - low flux - high flux - HDF | Experimental | Patients who are on hemodialysis will be treated with four different hemodialysis sessions:
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| low flux - high flux - MCO - HDF | Experimental |
| |
| high flux - HDF - low flux - MCO | Experimental |
| |
| HDF - MCO - high flux - low flux | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theranova 400 | Device | medium cut off (MCO) membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Troponin T - relative - 1 hour | Relative change from baseline (pre-treatment) to after 1 hour of hemodialysis in high sensitivity cardiac troponin T, assessed by Roche Elycsys Assay. | 1 hour after start of hemodialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Troponin T - relative - 4 hours | Relative change of high sensitivity cardiac troponin T from baseline to after completion of hemodialysis | 4 hours after start of hemodialysis |
| Troponin I - relative - 1 hour and 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander H Kirsch, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Austria |
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Randomized controlled four-treatment, four-period crossover trial
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| FX 10 | Device | low-flux membrane |
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| FX CorDiax 800 | Device | high-flux membrane |
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| HDF | Device | hemodiafiltration |
|
relative change of high sensitivity cardiac troponin I from baseline to after 1 hour and after completion of hemodialysis
| 1 hour and 4 hours after start of hemodialysis |
| Troponin T - absolute - 1 hour and 4 hours | absolute difference of high sensitivity cardiac troponin T from baseline to after 1 hour and after completion of hemodialysis | 1 hour and 4 hours after start of hemodialysis |
| Troponin I - absolute - 1 hour and 4 hours | absolute difference of high sensitivity cardiac troponin I from baseline to after 1 hour and after completion of hemodialysis | 1 hour and 4 hours after start of hemodialysis |