HPI for Prevention of Hypotension During Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Hypotension Prediction Index for Prevention of Hypotension During Cardiac Surgery: A Randomized Controlled Trial

Conditions
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Cardiac Surgery Patients

Intervention / Treatment
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* Device: Hypotension prediction index (HPI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult elective, primary, isolated coronary arterial bypass surgery (CABG) or isolated valve surgery provide inform consent. Exclusion Criteria: arrhythmia (e.g., atrial fibrillation, atrial flutter) intracardiac shunts preoperative inotropic usage preoperative supportive devices usage (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, left ventricular assist device, or right ventricular assist device) receiving urgent or emergent procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPI-guided<br>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)<br>* 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.<br>|
| No Intervention: non-HPI-guided<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, hypotension prediction index, hypotension, randomized controlled trial