Cardiac Surgery Patients
Conditions
Keywords
cardiac surgery, hypotension prediction index, hypotension, randomized controlled trial
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.
Interventions
DEVICEHypotension 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.
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | including acute kidney injury, arrhythmia, myocardial infarction determined by levels of cardiac enzymes, stroke, and mortality |
Countries
Taiwan
Contacts
Primary ContactYing-Chun Lin, Master
Outcome results
None listed