Smart dialysis machine aims to stop dangerous blood pressure drops
NCT ID NCT06376968
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a new feature on a dialysis machine that tries to predict and prevent sudden drops in blood pressure during treatment. About 56 adults on long-term dialysis who often have low blood pressure will be randomly assigned to use the feature or not, then switch. The goal is to see if the feature helps patients reach their target fluid removal safely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DialogiQ dialysis machine with BioLogic Fusion feedback system
- What this could lead to
- If it works, this could make dialysis safer and more comfortable for patients prone to low blood pressure.
- What could go wrong
- This is a small, early-stage study with only 56 participants, so results may not apply to everyone. The feature may not prevent all hypotensive episodes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female subjects ≥18 years of age * Chronic bicarbonate standard high-flux haemodialysis or hemodiafiltration for at least 3 months * Dialysis frequency 3 x per week * Dialysis duration per session ≥ 4h * Patient on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes * No residual renal function (definition: ≤100 ml urine/day) - changed to "No to minimal residual renal function (definition: ≤ 300 ml/day)" with Amendment 1 (CIP version 6) * Stable dry body weight for at least 4 weeks * Subjects who are willing to give a voluntary consent to participate in the study Exclusion Criteria: * Simultaneous participation in another interventional clinical trial (drugs or medical devices studies) * Vascular access insufficiency (mean blood flow \<200ml/min) * Patients treated with dialysis profiles: sodium profile, Ultrafiltration (UF) profile, and temperature profile - changed to: " Patients treated with dialysis profiles during the 9 prescreening visits: sodium profile, UF profile, and temperature profile. However, patients on sodium, ultrafiltration or temperature profiling expected to reduce intradialytic hypotensive episodes can be evaluated for enrollment when their frequency of sessions complicated by hypotension demonstrate the lack of efficacy of the applied profiles" with Amendment 1 (CIP version 6) * Use of the BioLogic fusion function during the last 9 dialysis sessions recorded at the site (retrospective screening period) * Pregnant or nursing women. Women of childbearing potential must agree to avoid pregnancy during the study period * Factors which may interfere with full participation in the trial * Any contra-indication to haemodialysis treatment per se, as described in the Instructions for Use (IFU) * Any serious medical condition or disability, which in the opinion of the investigator limits the life expectancy and would preclude completion of the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione
RECRUITINGBologna, Emilia-Romagna, 40138, Italy
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