Troponin TNCT05439681
Hs-Troponin T Kinetics in Patients Treated With MCO Membranes Compared to High-flux, Low-flux Membranes and HDF
A study testing Theranova 400, FX 10 and FX CorDiax 800 in people with Troponin T, run by Medical University of Graz at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Troponin T
- What is being tested?
- Theranova 400, FX 10 and FX CorDiax 800
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteAustria
- Study dates
- 12 Aug 2022to 24 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- minimum 18 years of age
- End stage kidney disease patient undergoing hemodialysis
- Written consent of the participant after being informed
Who cannot join
- No informed consent was obtained
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Troponin T
- Being tested
- Theranova 400, FX 10, FX CorDiax 800, HDF
- Keywords
- hemodialysis, low-flux dialysis, high-flux dialysis, medium cut-off membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theranova 400Device
medium cut off (MCO) membrane
FX 10Device
low-flux membrane
FX CorDiax 800Device
high-flux membrane
HDFDevice
hemodiafiltration
| Study group | Role | What they receive |
|---|---|---|
| MCO - low flux - high flux - HDF | Experimental | 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. Receives: Device: Theranova 400; Device: FX 10; Device: FX CorDiax 800; Device: HDF |
| low flux - high flux - MCO - HDF | Experimental | Not described Receives: Device: Theranova 400; Device: FX 10; Device: FX CorDiax 800; Device: HDF |
| high flux - HDF - low flux - MCO | Experimental | Not described Receives: Device: Theranova 400; Device: FX 10; Device: FX CorDiax 800; Device: HDF |
| HDF - MCO - high flux - low flux | Experimental | Not described Receives: Device: Theranova 400; Device: FX 10; Device: FX CorDiax 800; Device: HDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after start of hemodialysis
Secondary outcomes (4)
Troponin T - relative - 4 hours
Relative change of high sensitivity cardiac troponin T from baseline to after completion of hemodialysis
Measured: 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
Measured: 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
Measured: 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
Measured: 1 hour and 4 hours after start of hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start12 Aug 2022
- Primary completion24 Dec 2022
- Study completion24 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Troponin TStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized controlled four-treatment, four-period crossover trial
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander H Kirsch, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439681
- Sponsor's protocol ID
- TropT-HD
- Status last verified
- Mar 2023
- First submitted
- 27 Jun 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hs-Troponin T Kinetics in Patients Treated With MCO Membranes Compared to High-flux, Low-flux Membranes and HDF
- ClinicalTrials.gov ID
- NCT05439681
- Acronym / sponsor ID
- TropT-HD
- Conditions
- Troponin T
- Keywords
- hemodialysis, low-flux dialysis, high-flux dialysis, medium cut-off membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 24 Dec 2022 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized controlled four-treatment, four-period crossover trial
| Arm | Type | Receives |
|---|---|---|
| MCO - low flux - high flux - HDF | Experimental | Device: Theranova 400, Device: FX 10, Device: FX CorDiax 800, Device: HDFPatients 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 | Experimental | Device: Theranova 400, Device: FX 10, Device: FX CorDiax 800, Device: HDF |
| high flux - HDF - low flux - MCO | Experimental | Device: Theranova 400, Device: FX 10, Device: FX CorDiax 800, Device: HDF |
| HDF - MCO - high flux - low flux | Experimental | Device: Theranova 400, Device: FX 10, Device: FX CorDiax 800, Device: HDF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- minimum 18 years of age
- End stage kidney disease patient undergoing hemodialysis
- Written consent of the participant after being informed
Key exclusion criteria (2 listed)
- No informed consent was obtained
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theranova 400medium cut off (MCO) membrane | Device | HDF - MCO - high flux - low flux, MCO - low flux - high flux - HDF, high flux - HDF - low flux - MCO, low flux - high flux - MCO - HDF |
| FX 10low-flux membrane | Device | HDF - MCO - high flux - low flux, MCO - low flux - high flux - HDF, high flux - HDF - low flux - MCO, low flux - high flux - MCO - HDF |
| FX CorDiax 800high-flux membrane | Device | HDF - MCO - high flux - low flux, MCO - low flux - high flux - HDF, high flux - HDF - low flux - MCO, low flux - high flux - MCO - HDF |
| HDFhemodiafiltration | Device | HDF - MCO - high flux - low flux, MCO - low flux - high flux - HDF, high flux - HDF - low flux - MCO, low flux - high flux - MCO - HDF |
Primary outcome
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.
4 secondary outcomes
Troponin T - relative - 4 hours
Time frame: 4 hours after start of hemodialysis
Troponin I - relative - 1 hour and 4 hours
Time frame: 1 hour and 4 hours after start of hemodialysis
Troponin T - absolute - 1 hour and 4 hours
Time frame: 1 hour and 4 hours after start of hemodialysis
Troponin I - absolute - 1 hour and 4 hours
Time frame: 1 hour and 4 hours after start of hemodialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander H Kirsch, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theranova 400, FX 10 and FX CorDiax 800 in people with Troponin T, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin T - relative - 1 hour (time frame: 1 hour after start of hemodialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.