HPI for Prevention of Hypotension During Cardiac Surgery

NCT06137547 | Recruiting

• 1 other identifier: 20220800015
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgery Patients

Keywords

cardiac surgery; hypotension prediction index; hypotension; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  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

Study Arms (2)

HPI-guided

EXPERIMENTAL

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)

non-HPI-guided

NO INTERVENTION

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.

Interventions

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.

HPI-guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult
• elective, primary, isolated coronary arterial bypass surgery (CABG) or isolated valve surgery
• provide inform consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay memorial hospital

Taipei, 104, Taiwan

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ying-Chun Lin, Master

CONTACT

+886-02-25433535; elegant.beaver@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: November 20, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)