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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• adult

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

• provide inform consent.

Locations
Other Locations
Taiwan
Mackay memorial hospital
RECRUITING
Taipei
Contact Information
Primary
Ying-Chun Lin, Master
elegant.beaver@gmail.com
+886-02-25433535
Time Frame
Start Date: 2023-11-20
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 110
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Mackay Memorial Hospital

This content was sourced from clinicaltrials.gov