Hs-Troponin T Kinetics in Patients Treated With MCO Membranes Compared to High-flux, Low-flux Membranes and HDF
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedStudy Start
First participant enrolled
August 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 24, 2022
CompletedMarch 2, 2023
March 1, 2023
4 months
June 27, 2022
March 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Troponin T - relative - 4 hours
4 hours after start of hemodialysis
Troponin I - relative - 1 hour and 4 hours
1 hour and 4 hours after start of hemodialysis
Troponin T - absolute - 1 hour and 4 hours
1 hour and 4 hours after start of hemodialysis
Troponin I - absolute - 1 hour and 4 hours
1 hour and 4 hours after start of hemodialysis
Study Arms (4)
MCO - low flux - high flux - HDF
EXPERIMENTALPatients 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.
low flux - high flux - MCO - HDF
EXPERIMENTALhigh flux - HDF - low flux - MCO
EXPERIMENTALHDF - MCO - high flux - low flux
EXPERIMENTALInterventions
medium cut off (MCO) membrane
low-flux membrane
high-flux membrane
hemodiafiltration
Eligibility Criteria
You may qualify if:
- minimum 18 years of age
- End stage kidney disease patient undergoing hemodialysis
- Written consent of the participant after being informed
You may not qualify if:
- No informed consent was obtained
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz
Graz, Austria
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander H Kirsch, MD
Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2022
First Posted
June 30, 2022
Study Start
August 12, 2022
Primary Completion
December 24, 2022
Study Completion
December 24, 2022
Last Updated
March 2, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share