Hs-Troponin T Kinetics in Patients Treated With MCO Membranes Compared to High-flux, Low-flux Membranes and HDF

Medical University of Graz

Status: Completed

Conditions: Troponin T

Treatments: Device: FX CorDiax 800; Device: Theranova 400; Device: FX 10; Device: HDF

Study type: Interventional

Funder types: Other

Identifiers

NCT05439681

TropT-HD

Details and patient eligibility

About

In this study, 24 prevalent hemodialysis patients will undergo four regular hemodialysis sessions during which four different treatments will be performed.

• 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.

Full description

Patients who are on hemodialysis will be included in this study. After obtaining informed consent, patients will be treated with four different hemodialysis sessions:

• 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• minimum 18 years of age
• End stage kidney disease patient undergoing hemodialysis
• Written consent of the participant after being informed

Exclusion criteria

• No informed consent was obtained
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 4 patient groups

MCO - low flux - high flux - HDF

Experimental group

Description:

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.

Treatment:

Device: FX 10

Device: Theranova 400

Device: HDF

Device: FX CorDiax 800

low flux - high flux - MCO - HDF

Experimental group

Treatment:

Device: FX 10

Device: Theranova 400

Device: HDF

Device: FX CorDiax 800

high flux - HDF - low flux - MCO

Experimental group

Treatment:

Device: FX 10

Device: Theranova 400

Device: HDF

Device: FX CorDiax 800

HDF - MCO - high flux - low flux

Experimental group

Treatment:

Device: FX 10

Device: Theranova 400

Device: HDF

Device: FX CorDiax 800