HPI for Prevention of Hypotension During Cardiac Surgery

Cardiac Surgery Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137547
• Other study ID #: 20220800015
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: March 2024
• Source: Mackay Memorial Hospital
• Contact: Ying-Chun Lin, Master
• Phone: +886-02-25433535
• Email: elegant.beaver[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery Patients
• Hypotension

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Mackay memorial hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	incidence of hypotension		from induction to the end of surgery (excluding CPB time)
Secondary	duration of hypotension		from induction to the end of surgery (excluding CPB time)
Secondary	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
Secondary	length of ICU stay		after surgery until ICU discharge, assessed up to 30 days
Secondary	length of hospital stay		after surgery until hospital discahrge, assessed up to 30 days