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Completed

NCT Number: NCT05439681

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.

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Key information

Conditions

Troponin T

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theranova 400

Device

medium cut off (MCO) membrane

FX 10

Device

low-flux membrane

FX CorDiax 800

Device

high-flux membrane

HDF

Device

hemodiafiltration

Primary outcomes

  1. Troponin T - relative - 1 hour

    Time frame: 1 hour after start of hemodialysis

    Relative change from baseline (pre-treatment) to after 1 hour of hemodialysis in high sensitivity cardiac troponin T, assessed by Roche Elycsys Assay.

Secondary outcomes

  1. Troponin T - relative - 4 hours

    Time frame: 4 hours after start of hemodialysis

    Relative change of high sensitivity cardiac troponin T from baseline to after completion of hemodialysis

  2. Troponin I - relative - 1 hour and 4 hours

    Time frame: 1 hour and 4 hours after start of hemodialysis

    relative change of high sensitivity cardiac troponin I from baseline to after 1 hour and after completion of hemodialysis

  3. Troponin T - absolute - 1 hour and 4 hours

    Time frame: 1 hour and 4 hours after start of hemodialysis

    absolute difference of high sensitivity cardiac troponin T from baseline to after 1 hour and after completion of hemodialysis

  4. Troponin I - absolute - 1 hour and 4 hours

    Time frame: 1 hour and 4 hours after start of hemodialysis

    absolute difference of high sensitivity cardiac troponin I from baseline to after 1 hour and after completion of hemodialysis

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2022
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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