HPI for Prevention of Hypotension During Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Cardiac Surgery Patients
• Interventions: Device: Hypotension prediction index (HPI)

• Registration Number: NCT06137547
• Lead Sponsor: Mackay Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-11
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Study Start: 2023-11-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Primary Completion: 2027-07-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPI-guided	Hypotension prediction index (HPI)	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.

Primary Outcome Measures

Name	Time	Method
TWA (time-weighted average) of intraoperative hypotension	From induction to the end of surgery. (If cardiopulmonary bypass (CPB) is adopted, the time of CPB will not be counted in)	Time-weighted average of intraoperative hypotension below 65 mmHg

Secondary Outcome Measures

Name	Time	Method
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
duration of hypotension	from induction to the end of surgery (excluding CPB time)
postoperative complications	after surgery until discharge, assessed up to 30 days	including acute kidney injury, arrhythmia, myocardial infarction determined by levels of cardiac enzymes, stroke, and mortality
incidence of hypotension	from induction to the end of surgery (excluding CPB time)

Trial Locations

Locations (1)

Mackay memorial hospital; 🇨🇳 Taipei, Taiwan