NCT06137547 HPI for Prevention of Hypotension During Cardiac Surgery

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 110 participants in total. It began in 2023-11-20 with a primary completion date of 2027-07-31.

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.

Eligibility Criteria

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.

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