An interventional study of Theranova 400 and FX 10 in Troponin T, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Diagnostic
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.
Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who are on hemodialysis will be treated with four different hemodialysis sessions: * Treatment 1: MCO membrane * Treatment 2: low flux membrane * Treatment 3: high flux membrane * Treatment 4: HDF treatment with high flux membrane The order of the treatment regimens with the different membranes will be randomized.
Device: Theranova 400 · Device: FX 10 · Device: FX CorDiax 800 · Device: HDF
Device: Theranova 400 · Device: FX 10 · Device: FX CorDiax 800 · Device: HDF
Device: Theranova 400 · Device: FX 10 · Device: FX CorDiax 800 · Device: HDF
Device: Theranova 400 · Device: FX 10 · Device: FX CorDiax 800 · Device: HDF
medium cut off (MCO) membrane
low-flux membrane
high-flux membrane
hemodiafiltration
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.
Time frame: 1 hour after start of hemodialysis
Troponin T - relative - 4 hours
Relative change of high sensitivity cardiac troponin T from baseline to after completion of hemodialysis
Time frame: 4 hours after start of hemodialysis
Troponin I - relative - 1 hour and 4 hours
relative change of high sensitivity cardiac troponin I from baseline to after 1 hour and after completion of hemodialysis
Time frame: 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
Time frame: 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
Time frame: 1 hour and 4 hours after start of hemodialysis
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Medical University of Graz