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Smart dialysis machine aims to stop dangerous blood pressure drops

NCT ID NCT06376968

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione

    RECRUITING

    Bologna, Emilia-Romagna, 40138, Italy

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