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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06137547
Other study ID # 20220800015
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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