Hs-Troponin T Kinetics in Patients Treated With MCO Membranes Compared to High-flux, Low-flux Membranes and HDF
NCT ID: NCT05439681
Last Updated: 2023-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2022-08-12
2022-12-24
Brief Summary
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* Treatment 1: MCO membrane (=medium cut off)
* Treatment 2: low flux membrane
* Treatment 3: high flux membrane
* Treatment 4: HDF(=hemodiafiltration) treatment with high flux membrane
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.
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Detailed Description
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* Treatment 1: MCO membrane (=medium cut off)
* Treatment 2: low flux membrane
* Treatment 3: high flux membrane
* Treatment 4: HDF(=hemodiafiltration) treatment with high flux membrane The order of the treatment regimens with the different membranes will be randomized in four sequences (Williams design).
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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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MCO - low flux - high flux - HDF
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.
Theranova 400
medium cut off (MCO) membrane
FX 10
low-flux membrane
FX CorDiax 800
high-flux membrane
HDF
hemodiafiltration
low flux - high flux - MCO - HDF
Theranova 400
medium cut off (MCO) membrane
FX 10
low-flux membrane
FX CorDiax 800
high-flux membrane
HDF
hemodiafiltration
high flux - HDF - low flux - MCO
Theranova 400
medium cut off (MCO) membrane
FX 10
low-flux membrane
FX CorDiax 800
high-flux membrane
HDF
hemodiafiltration
HDF - MCO - high flux - low flux
Theranova 400
medium cut off (MCO) membrane
FX 10
low-flux membrane
FX CorDiax 800
high-flux membrane
HDF
hemodiafiltration
Interventions
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Theranova 400
medium cut off (MCO) membrane
FX 10
low-flux membrane
FX CorDiax 800
high-flux membrane
HDF
hemodiafiltration
Eligibility Criteria
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Inclusion Criteria
* End stage kidney disease patient undergoing hemodialysis
* Written consent of the participant after being informed
Exclusion Criteria
* Pregnancy
18 Years
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Alexander H Kirsch, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
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Medical University of Graz
Graz, , Austria
Countries
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Other Identifiers
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TropT-HD
Identifier Type: -
Identifier Source: org_study_id
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