Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission (NCT05821647) | Clinical Trial Compass
CompletedNot Applicable
Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission
Netherlands130 participantsStarted 2021-05-20
Plain-language summary
This trial registration serves as an amendment incorporating the IPD Sharing Statement.
This study already has a trial registration (2021 April 30) in the Netherlands Trial Registry (Reference number NL9449, https://trialsearch.who.int/). However, the NTR register is subject to a merger with another Dutch register. This means that existing registrations are still visible, but can no longer be adjusted.
Study summary:
Hypotension in the operating room (OR) and during post-operative ICU admission is common in surgical patients and even more prevalent in cardiac surgery patients. It is associated with adverse outcomes and while these events are preventable, current management is predominantly reactive. Edwards Lifesciences (Irvine, CA) has developed the Hypotension Prediction Index (HPI), an early warning system that predicts an hypotensive event, defined as MAP below 65 mmHg, with high accuracy minutes before it occurs. At the time of writing the protocol this model has not been tested in a clinical trial in cardiac surgery patients or ICU admitted patients. The aim of the HYPE-2 trial is to assess whether the HPI-algorithm can reduce the time-weighted average (TWA) of intra- and postoperative hypotension in elective on-pump coronary artery bypass graft (CABG) surgery patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years or older at inclusion
* Planned for elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement)
* Planned to receive standard monitoring for cardiac surgery
* Target MAP of 65 mmHg or above during surgery
* Target MAP of 65 mmHg or above during the mechanically ventilated phase of ICU admission
Exclusion Criteria:
* Known cardiac shunts (significant)
* Severe cardiac arrhythmias (including but not limited to persistent atrial fibrillation prior to surgery)
* Expected to receive an hemodynamic assist device (e.g. intra-aortic balloon pump) during surgery
* Dialysis dependent kidney failure prior to surgery
* Planned to receive Perioperative Goal Directed Therapy (PGDT) other than standard intraoperative care
* Previous cardiac surgery in medical history
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The overall time-weighted average (TWA) of hypotension (severity of hypotension)
Timeframe: During both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Trial details
NCT IDNCT05821647
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)