HPI for Prevention of Hypotension During Cardiac Surgery

Mackay Memorial Hospital

Status: Enrolling

Conditions: Cardiac Surgery Patients

Treatments: Device: Hypotension prediction index (HPI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06137547

20220800015

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

HPI-guided

Experimental group

Description:

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.

Treatment:

Device: Hypotension prediction index (HPI)

non-HPI-guided

No Intervention group

Description:

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.