HPI for Prevention of Hypotension During Cardiac Surgery

Hypotension Prediction Index for Prevention of Hypotension During Cardiac Surgery: A Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery Patients
• Intervention / Treatment: Device: Hypotension prediction index (HPI)

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying-Chun Lin, Master; Phone Number: 3009 +886-02-25433535; Email: elegant.beaver@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 104
    • Recruiting
    • Mackay Memorial Hospital
    • Contact: Yingchun Lin, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPI-guided; 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); 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.
No Intervention: non-HPI-guided; 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?

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

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: November 11, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; randomized controlled trial; hypotension; hypotension prediction index
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: 20220800015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not understand the individual patient data (IPD) sharing platform through enough.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No