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

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.

Study Overview

• Status: Completed
• Conditions: Troponin T
• Intervention / Treatment: Device: Theranova 400; Device: FX 10; Device: FX CorDiax 800; Device: HDF

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Theranova 400; medium cut off (MCO) membrane; Device: FX 10; low-flux membrane; Device: FX CorDiax 800; high-flux membrane; Device: HDF; hemodiafiltration
Experimental: low flux - high flux - MCO - HDF	Device: Theranova 400; medium cut off (MCO) membrane; Device: FX 10; low-flux membrane; Device: FX CorDiax 800; high-flux membrane; Device: HDF; hemodiafiltration
Experimental: high flux - HDF - low flux - MCO	Device: Theranova 400; medium cut off (MCO) membrane; Device: FX 10; low-flux membrane; Device: FX CorDiax 800; high-flux membrane; Device: HDF; hemodiafiltration
Experimental: HDF - MCO - high flux - low flux	Device: Theranova 400; medium cut off (MCO) membrane; Device: FX 10; low-flux membrane; Device: FX CorDiax 800; high-flux membrane; Device: HDF; hemodiafiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Alexander H Kirsch, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2022
• Primary Completion (Actual): December 24, 2022
• Study Completion (Actual): December 24, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: hemodialysis; low-flux dialysis; high-flux dialysis; medium cut-off membrane
• Other Study ID Numbers: TropT-HD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No