Cardiac Surgery Patients Clinical Trial
Official title:
Hypotension Prediction Index for Prevention of Hypotension During Cardiac Surgery: A Randomized Controlled Trial
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.
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Mackay memorial hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Mackay Memorial Hospital |
Taiwan,
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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