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

Study Overview
=================
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.

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

Conditions
-----------------
Troponin T

Intervention / Treatment
-----------------
* Device: Theranova 400
* Device: FX 10
* Device: FX CorDiax 800
* Device: HDF


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized controlled four-treatment, four-period crossover trial
Masking: None (Open Label)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, low-flux dialysis, high-flux dialysis, medium cut-off membrane