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New device predicts dangerous drops in blood pressure after heart surgery

NCT ID NCT05964374

Disease control Sponsor: University of Calgary Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a goal-directed therapy system that uses a special monitor and algorithm to predict low blood pressure in 100 adults after heart surgery. The device helped guide doctors on when to give fluids or medications to keep blood pressure stable. The goal was to see if this approach works better than standard care in the intensive care unit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Goal-directed therapy using HemoSphere monitor, Acumen transducer, and Hypotension Prediction Index algorithm
What this could lead to
If successful, this approach could help doctors better manage blood pressure after heart surgery, potentially reducing complications and speeding recovery.
What could go wrong
This is a small pilot study with only 100 participants, so results may not apply to all patients. The device is a tool, not a cure, and its benefit over standard care is not yet proven.

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

100 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

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: 1. ≥ 18 years of age 2. Planned cardiac surgery using cardiopulmonary bypass (sternotomy or MICS) 3. Preoperative European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) of 2% or more. 4. Informed consent obtained. Exclusion Criteria: 1. Emergency surgery 2. Patients who refuse participation 3. Patients who are unable to give informed consent 4. Patients who are having a heart or lung transplant. 5. Surgery for insertion of any ventricular assist device 6. Aortic arch procedures with any degree of debranching or hybrid with endovascular intervention in the ascending aorta +/- arch. 7. Patients who require MCS (including ECMO, Impella, or IABP) post-operatively 8. Patients on contact/droplet isolation. 9. Patients deemed excessively unstable and/or complex by their attending intensivist on arrival to the ICU. 10. If the post-operative arterial line MAP goal is not 65 mmHg. 11. Patients who suffer intra-operative mortality.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Surgery

Contacts and locations

Locations

  • Foothills Medical Centre

    Calgary, Alberta, T2N2T9, Canada

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