Clinical trial NCT05439681: Hs-Troponin T Kinetics in Patients Treated With MCO Membranes Compared to High-flux, Low-flux Membranes and HDF
Official title: Hs-Troponin T Kinetics in Patients Treated With MCO Membranes Compared to High-flux, Low-flux Membranes and HDF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Troponin T
Keywords: hemodialysis
low-flux dialysis
high-flux dialysis
medium cut-off membrane
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized controlled four-treatment, four-period crossover trial
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Troponin T - relative - 1 hour
timeFrame: 1 hour after start of hemodialysis
Secondary outcomes:
measure: Troponin T - relative - 4 hours
timeFrame: 4 hours after start of hemodialysis
measure: Troponin I - relative - 1 hour and 4 hours
timeFrame: 1 hour and 4 hours after start of hemodialysis
measure: Troponin T - absolute - 1 hour and 4 hours
timeFrame: 1 hour and 4 hours after start of hemodialysis
measure: Troponin I - absolute - 1 hour and 4 hours
timeFrame: 1 hour and 4 hours after start of hemodialysis
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Alexander H Kirsch, MD
role: PRINCIPAL_INVESTIGATOR
References: