HypotensionPhase 4AIMSNCT01414842
HFR A-equilibrium on Cardiovascular Stability
A Phase 4 study testing Automated sodium profiling in endogenous hemodiafiltration and Standard sodium dialysate in people with Hypotension, run by Azienda Ospedaliera di Lecco at 12 sites in 5 countries.
Trial summary
Aim of the present randomized controlled multinational trial is the comparison of a novel biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy, with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic overall and cardiovascular stability. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypotension
- What is being tested?
- Automated sodium profiling in endogenous hemodiafiltration and Standard sodium dialysate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Apr 2007to Dec 2008
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with more than 30% of dialysis complicated by hypotension
- age between 18 and 85 yers
- time on dialysis greater than 6 months
- residual creatinine clearance less than 2 ml/min/1.73 m2
- native fistula or central venous catheter with blood flow rate greater than 250 ml/min
Who cannot join
- Life expectancy less than 1 year
- solid active neoplasm
- pregnancy
- major event in the previous 3 months (ictus, myocardial infarction, cachexia)
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Italy7 sites
Nephrology and Dialysis Unit Ospedali Riuniti
Ancona
UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi
Bologna, 40128
Civil Hospital
Cirié
PO Lastaria
Foggia
Hospital Maggiore della Carità
Novara
Casa Sollievo della Sofferenza
San Giovanni Rotondo
Ospedale San Giovanni Bosco
Torino
France2 sites
Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat
Paris
Civil Hospital Bretagne Atlantique
Vannes
About this study
Official title: Randomized Controlled Study on the Effect of the Hemodiafiltration Plasma Sodium Biofeedback System on Cardiovascular Stability in Hemodialysis Patients
Aim of the present randomized controlled multinational trial is the comparison of a novel biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy, with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic overall and cardiovascular stability.
Read the detailed description
Online hemodiafiltration (OL-HDF) has been recently associated with better patient survival in comparison with standard hemodialysis in some large observational studies (Canaud et al, KI, 2006; Vilar et al, CJASN , 2009) supporting the hypothesis that convection can improve patients outcomes. Moreover, it has been demonstrated in randomized controlled trials (Locatelli et al, Journal American Society of Nephrology, 2010) that OL-HDF significantly reduced the frequency of intradialytic hypotension. Nonetheless, the associated comorbidities and ageing of dialysis population require further devices able to improve treatment tolerance. Among these tools, the sodium profiling and biofeedback system seem to be promising to accomplish this task. But the correct intradialytic sodium balance is still far away today to be easily achieved. The use of an automated adaptive system dialysis to the sodium profiling has been investigated in a feasibility trial (Colì et al International Journal Artificial Organs, 2003). They also investigated the impact of such a device on treatment tolerance.
The aim of this randomized multinational multicenter controlled trial is to evaluate the impact of sodium profiling applied to a endogenous hemodiafiltration technique on the intradialytic cardiovascular stability in comparison to standard no profiled endogenous hemodiafiltration.
- Conditions
- Hypotension
- Being tested
- Automated sodium profiling in endogenous hemodiafiltration, Standard sodium dialysate
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated sodium profiling in endogenous hemodiafiltrationDevice
Also called HFR-Aequilibrium
Automated sodium profiling during endogenous reinfusion hemodiafiltration technique. The device processes the dialysate sodium and ultrafiltration rate during dialysis to achieve a preset sodium target at the end of the treatment. Sodium dialysate and maximal ultrafiltration rate are constraint within safety limits during dialysis.
Standard sodium dialysateDevice
Also called Standard HFR
Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration Receives: Device: Standard sodium dialysate |
| Automated profiled | Experimental | Automate sodium profiling in endogenous hemodiafiltration Receives: Device: Automated sodium profiling in endogenous hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dialysis complicated by at least one hypotension
Hypotension definition:
If predialysis systolic blood pressure greater than100 mmHg then a value during dialysis below 90 mmHg or any systolic blood pressure reduction greater than 25 mmHg in presence of symptoms or If predialysis systolic blood pressure less than 90 mmHg a reduction of at least 10% accompanied by symptoms
Measured: six months
Secondary outcomes (1)
Blood Pressure Intradialytic symptoms
Systolic, diastolic blood pressures (SBP, DBP) and heart rate (HR) measured at the beginning of each treatment and every 30 minutes till the end of dialysis; intradialytic symptoms (nausea, vomiting, hypotension, headache, cramps) and related clinical interventions.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startApr 2007
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Lecco
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Centre Pasteur Vallery Radot
- Responsible party
- Principal investigator, Francesco Locatelli, Azienda Ospedaliera di Lecco
- Investigators
- Francesco Locatelli, Prof., Study chair, Azienda Ospedaliera di Lecco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414842
- Sponsor's protocol ID
- HFR-AE-2006
- Other IDs
- HFR-BFBCK0611
- Acronym
- AIMS
- Status last verified
- Jan 2007
- First submitted
- 10 Aug 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
PubMed 39498822
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on the Effect of the Hemodiafiltration Plasma Sodium Biofeedback System on Cardiovascular Stability in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01414842
- Acronym / sponsor ID
- AIMS / HFR-AE-2006
- Conditions
- Hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di LeccoUniversity, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Centre Pasteur Vallery Radot
- Study start
- Apr 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Aug 2011 (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.
Aim of the present randomized controlled multinational trial is the comparison of a novel biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy, with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic overall and cardiovascular stability.
Detailed description
Online hemodiafiltration (OL-HDF) has been recently associated with better patient survival in comparison with standard hemodialysis in some large observational studies (Canaud et al, KI, 2006; Vilar et al, CJASN , 2009) supporting the hypothesis that convection can improve patients outcomes. Moreover, it has been demonstrated in randomized controlled trials (Locatelli et al, Journal American Society of Nephrology, 2010) that OL-HDF significantly reduced the frequency of intradialytic hypotension. Nonetheless, the associated comorbidities and ageing of dialysis population require further devices able to improve treatment tolerance. Among these tools, the sodium profiling and biofeedback system seem to be promising to accomplish this task. But the correct intradialytic sodium balance is still far away today to be easily achieved. The use of an automated adaptive system dialysis to the sodium profiling has been investigated in a feasibility trial (Colì et al International Journal Artificial Organs, 2003). They also investigated the impact of such a device on treatment tolerance.
The aim of this randomized multinational multicenter controlled trial is to evaluate the impact of sodium profiling applied to a endogenous hemodiafiltration technique on the intradialytic cardiovascular stability in comparison to standard no profiled endogenous hemodiafiltration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Device: Standard sodium dialysateStandard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration |
| Automated profiled | Experimental | Device: Automated sodium profiling in endogenous hemodiafiltrationAutomate sodium profiling in endogenous hemodiafiltration |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with more than 30% of dialysis complicated by hypotension
- age between 18 and 85 yers
- time on dialysis greater than 6 months
- residual creatinine clearance less than 2 ml/min/1.73 m2
- native fistula or central venous catheter with blood flow rate greater than 250 ml/min
Key exclusion criteria (4 listed)
- Life expectancy less than 1 year
- solid active neoplasm
- pregnancy
- major event in the previous 3 months (ictus, myocardial infarction, cachexia)
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 |
|---|---|---|
| Automated sodium profiling in endogenous hemodiafiltrationAlso: HFR-AequilibriumAutomated sodium profiling during endogenous reinfusion hemodiafiltration technique. The device processes the dialysate sodium and ultrafiltration rate during dialysis to achieve a preset sodium target at the end of the treatment. Sodium dialysate and maximal ultrafiltration rate are constraint within safety limits during dialysis. | Device | Automated profiled |
| Standard sodium dialysateAlso: Standard HFRStandard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration | Device | Standard |
Primary outcome
Number of dialysis complicated by at least one hypotension
Time frame: six months
Hypotension definition: If predialysis systolic blood pressure greater than100 mmHg then a value during dialysis below 90 mmHg or any systolic blood pressure reduction greater than 25 mmHg in presence of symptoms or If predialysis systolic blood pressure less than 90 mmHg a reduction of at least 10% accompanied by symptoms
1 secondary outcome
Blood Pressure Intradialytic symptoms
Time frame: six months
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 29 Aug 2011.
- Derived from this study: PubMed 39498822Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
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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.
Francesco Locatelli, Prof. study chair
Azienda Ospedaliera di Lecco
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Automated sodium profiling in endogenous hemodiafiltration and Standard sodium dialysate in people with Hypotension, run by Azienda Ospedaliera di Lecco at 12 sites in 5 countries.
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 5 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 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, France, Belgium, Germany, Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of dialysis complicated by at least one hypotension (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414842, which also lists 1 linked publication.
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 29 Aug 2011.