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HPI for Prevention of Hypotension During Cardiac Surgery

ConditionCardiac Surgery Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMackay Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult

elective, primary, isolated coronary arterial bypass surgery (CABG) or isolated valve surgery

provide inform consent.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: HPI-guidedExperimental treatment 1 intervention
Group B: non-HPI-guidedNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

incidence of hypotension

Time frame
from induction to the end of surgery (excluding CPB time)
2

duration of hypotension

Time frame
from induction to the end of surgery (excluding CPB time)
3

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
4

length of ICU stay

Time frame
after surgery until ICU discharge, assessed up to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mackay Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov
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