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

Troponin T Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05439681
• Other study ID #: TropT-HD
• Status: Completed
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: December 24, 2022

Study information

• Verified date: March 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 24, 2022
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Troponin T

Intervention

Device:
• Theranova 400
medium cut off (MCO) membrane
• FX 10
low-flux membrane
• FX CorDiax 800
high-flux membrane
• HDF
hemodiafiltration

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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