An interventional study of Hypotension prediction index (HPI) in Cardiac Surgery Patients, sponsored by Mackay Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Mackay Memorial Hospital · Not applicable, Interventional, and Prevention
Hypotension prediction index (HPI) was applied in various types of non-cardiac surgery with convincing benefits of preventing hypotensive events and clinical sequelae. Although HPI was validated in cardiac surgery, its clinical benefits are not proven yet. We aim to evaluate its effects on intraoperative hypotension and postoperative adverse events in cardiac surgery. In this randomized, single-blind trial, we will enroll adults scheduled for elective primary cardiac surgery under general anesthesia. Participants will be randomly assigned to intraoperative HPI-guided or non-HPI-guided hemodynamic management. The primary endpoint is the time-weighted average intraoperative hypotension below a mean arterial pressure threshold of 65 mmHg. The secondary endpoints are postoperative complications.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 110 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The arterial line of patients in HPI-guided arm will be connected to HemoSphere advanced monitoring platform (EV1000), which will provide HPI value calculated with Acumen Hypotension Prediction Index software.
Device: Hypotension prediction index (HPI)
The arterial line of patients in non-HPI-guided arm will also be connected to HemoSphere advanced monitoring platform (EV1000) and all hemodynamic parameters will be calculated and showed as HPI-guided arm EXCEPT that the HPI value will not be shown on screen.
The hypotension prediction index (HPI) is a value derived from the arterial pressure waveform. It was invented by Edwards Lifesciences through a machine-learning algorithm, and can be calculated with Acumen Hypotension Prediction Index software incorporated in HemoSphere advanced monitoring platform (EV1000). This value, ranging from 0 to 100, predicts the likelihood of a patient trending towards a hypotensive event, which is defined as mean arterial pressure below 65 mmHg for at least one minute.
TWA (time-weighted average) of intraoperative hypotension
Time-weighted average of intraoperative hypotension below 65 mmHg
Time frame: From induction to the end of surgery. (If cardiopulmonary bypass (CPB) is adopted, the time of CPB will not be counted in)
incidence of hypotension
Time frame: from induction to the end of surgery (excluding CPB time)
duration of hypotension
Time frame: from induction to the end of surgery (excluding CPB time)
postoperative complications
including acute kidney injury, arrhythmia, myocardial infarction determined by levels of cardiac enzymes, stroke, and mortality
Time frame: after surgery until discharge, assessed up to 30 days
length of ICU stay
Time frame: after surgery until ICU discharge, assessed up to 30 days
length of hospital stay
Time frame: after surgery until hospital discahrge, assessed up to 30 days
Plan to share: No — Not understand the individual patient data (IPD) sharing platform through enough.
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Mackay Memorial Hospital