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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPI-guided | Experimental | 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. |
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| non-HPI-guided | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypotension prediction index (HPI) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TWA (time-weighted average) of intraoperative hypotension | Time-weighted average of intraoperative hypotension below 65 mmHg | From induction to the end of surgery. (If cardiopulmonary bypass (CPB) is adopted, the time of CPB will not be counted in) |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of hypotension | from induction to the end of surgery (excluding CPB time) | |
| duration of hypotension | from induction to the end of surgery (excluding CPB time) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying-Chun Lin, Master | Contact | +886-02-25433535 | 3009 | elegant.beaver@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay memorial hospital | Recruiting | Taipei | 104 | Taiwan |
Not understand the individual patient data (IPD) sharing platform through enough.
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| postoperative complications |
including acute kidney injury, arrhythmia, myocardial infarction determined by levels of cardiac enzymes, stroke, and mortality |
| after surgery until discharge, assessed up to 30 days |
| length of ICU stay | after surgery until ICU discharge, assessed up to 30 days |
| length of hospital stay | after surgery until hospital discahrge, assessed up to 30 days |