HPI for Prevention of Hypotension During Cardiac Surgery

Mackay Memorial Hospital110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

110

Conditions

Cardiac Surgery Patients

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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