Dialysis Membranes and Hemodynamic ToleranceNCT01898234
Dialysis Membranes and Hemodynamic Tolerance
A study testing Revaclear, Helixone high flux and Xevonta in people with Dialysis Membranes and Hemodynamic Tolerance, run by Ospedale Regionale di Locarno at 1 site in Switzerland.
Trial summary
Background: High- and low-flux dialysis membranes made of different materials may correlate with various hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and incidence of hypotensive episodes by comparing some of the most commonly used high- and low-flux dialyzers. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Dialysis Membranes and Hemodynamic Tolerance
- What is being tested?
- Revaclear, Helixone high flux and Xevonta
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to Jan 2013
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 and older
- ability to understand the information presented and sign the informed consent
- chronic hemodialysis for at least 8 weeks
- stable dialysis prescriptions and modality in the 2 weeks prior to protocol implementation
Who cannot join
- mental illness;
- inability to understand the information presented and sign the informed consent;
- acute disease requiring hospitalization at the time of patient enrolment
- pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale di Locarno
Locarno, Canton Ticino, 6928
About this study
Official title: Assessment of Subjective and Hemodynamic Tolerance of Different High- and Low-flux Dialysis Membranes in Patients Undergoing Chronic Intermittent Hemodialysis: a Randomized Controlled Trial
Background:
High- and low-flux dialysis membranes made of different materials may correlate with various hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and incidence of hypotensive episodes by comparing some of the most commonly used high- and low-flux dialyzers.
Read more
Methodology:
The study was designed as an open label, randomized, cross-over investigation, including 25 patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other. The hemodynamic profile was assessed with a non-invasive technique and patients were asked to provide tolerance feedback through a questionnaire.
- Being tested
- Revaclear, Helixone high flux, Xevonta, Helixone low flux
- Keywords
- Hemodynamics, intradialytic hypotension, subjective tolerance, dialysis membranes, high flux, low flux, hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevaclearDevice
Also called -Revaclear, Gambro 1.8 m2
Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other
Helixone high fluxDevice
Also called Helixone high flux, Fresenius 1.8 m2
Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other
XevontaDevice
Also called Xevonta, BBraun 1.8 m2
Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other
Helixone low fluxDevice
Also called Helixone low flux, Fresenius 1.8 m2
Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other
| Study group | Role | What they receive |
|---|---|---|
| Revaclear | Experimental | Not described Receives: Device: Revaclear |
| Helixone high flux | Experimental | Not described Receives: Device: Helixone high flux |
| Xevonta | Experimental | Not described Receives: Device: Xevonta |
| Helixone low flux | Experimental | Not described Receives: Device: Helixone low flux |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis
Measured: 4 weeks
comparative evaluation of subjective tolerance across the various membranes
As to the assessment of subjective tolerance, we decided to administer the questionnaire designed by Cruz et al. [Cruz DN, Mahnensmith RL, Brickel HM, Perazella MA. Midodrine and cool dialysate are effective therapies for symptomatic intradialytic hypotension. Am. J. Kidney Dis. 1999 Mag;33(5):920-926] then modified by Teruel et al. [Teruel JL, Martins J, Merino JL, Fernández Lucas M, Rivera M, Marcén R, et al. Temperature of the dialysis bath and hemodialysis tolerance. Nefrología: PublicaciónOficial De La Sociedad Española Nefrologia. 2006;26(4):461-468] and to integrate it with a 1 to 10 numerical scale to assess patient well-being
Measured: 4 weeks
comparative evaluation of Kt/V and of beta-2 microglobulin removal
Measured: 4 weeks
Secondary outcomes (1)
comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Membranes and Hemodynamic ToleranceStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale di Locarno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Gabutti, MD, Ospedale Regionale di Locarno
- Investigators
- Luca Gabutti, MD, Principal investigator, Ospedale Regionale Locarno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898234
- Sponsor's protocol ID
- 012012
- Status last verified
- Jul 2013
- First submitted
- 2 Jul 2013
- Last updated
- 12 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Subjective and Hemodynamic Tolerance of Different High- and Low-flux Dialysis Membranes in Patients Undergoing Chronic Intermittent Hemodialysis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01898234
- Acronym / sponsor ID
- 012012
- Keywords
- Hemodynamics, intradialytic hypotension, subjective tolerance, dialysis membranes, high flux, low flux, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ospedale Regionale di LocarnoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Jul 2013 (estimated)
- 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.
Background:
High- and low-flux dialysis membranes made of different materials may correlate with various hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and incidence of hypotensive episodes by comparing some of the most commonly used high- and low-flux dialyzers.
Methodology:
The study was designed as an open label, randomized, cross-over investigation, including 25 patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other. The hemodynamic profile was assessed with a non-invasive technique and patients were asked to provide tolerance feedback through a questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Revaclear | Experimental | Device: Revaclear |
| Helixone high flux | Experimental | Device: Helixone high flux |
| Xevonta | Experimental | Device: Xevonta |
| Helixone low flux | Experimental | Device: Helixone low flux |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 and older
- ability to understand the information presented and sign the informed consent
- chronic hemodialysis for at least 8 weeks
- stable dialysis prescriptions and modality in the 2 weeks prior to protocol implementation
Key exclusion criteria (4 listed)
- mental illness;
- inability to understand the information presented and sign the informed consent;
- acute disease requiring hospitalization at the time of patient enrolment
- pregnancy and breast feeding
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 |
|---|---|---|
| RevaclearAlso: -Revaclear, Gambro 1.8 m2Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other | Device | Revaclear |
| Helixone high fluxAlso: Helixone high flux, Fresenius 1.8 m2Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other | Device | Helixone high flux |
| XevontaAlso: Xevonta, BBraun 1.8 m2Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other | Device | Xevonta |
| Helixone low fluxAlso: Helixone low flux, Fresenius 1.8 m2Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other | Device | Helixone low flux |
Primary outcome
comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis
Time frame: 4 weeks
comparative evaluation of subjective tolerance across the various membranes
Time frame: 4 weeks
As to the assessment of subjective tolerance, we decided to administer the questionnaire designed by Cruz et al. [Cruz DN, Mahnensmith RL, Brickel HM, Perazella MA. Midodrine and cool dialysate are effective therapies for symptomatic intradialytic hypotension. Am. J. Kidney Dis. 1999 Mag;33(5):920-926] then modified by Teruel et al. [Teruel JL, Martins J, Merino JL, Fernández Lucas M, Rivera M, Marcén R, et al. Temperature of the dialysis bath and hemodialysis tolerance. Nefrología: PublicaciónOficial De La Sociedad Española Nefrologia. 2006;26(4):461-468] and to integrate it with a 1 to 10 numerical scale to assess patient well-being
comparative evaluation of Kt/V and of beta-2 microglobulin removal
Time frame: 4 weeks
1 secondary outcome
comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg)
Time frame: 4 weeks
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 12 Jul 2013.
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.
Luca Gabutti, MD principal investigator
Ospedale Regionale Locarno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revaclear, Helixone high flux and Xevonta in people with Dialysis Membranes and Hemodynamic Tolerance, run by Ospedale Regionale di Locarno at 1 site in Switzerland.
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 4 inclusion and 4 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 12 Jul 2013. 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 Switzerland. 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?
comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 12 Jul 2013.