HPI for Prevention of Hypotension During Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypotension prediction index (HPI).
- Who it may be relevant to
- Registry conditions: Cardiac Surgery Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hypotension Prediction Index for Prevention of Hypotension During Cardiac Surgery: A Randomized Controlled Trial
Overview
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
- 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 minut
Primary outcome measures
- TWA (time-weighted average) of intraoperative hypotension [Time frame: From induction to the end of surgery. (If cardiopulmonary bypass (CPB) is adopted, the time of CPB will not be counted in)]
Secondary outcome measures (5)
- incidence of hypotension [Time frame: from induction to the end of surgery (excluding CPB time)]
- duration of hypotension [Time frame: from induction to the end of surgery (excluding CPB time)]
- postoperative complications [Time frame: after surgery until discharge, assessed up to 30 days]
- length of ICU stay [Time frame: after surgery until ICU discharge, assessed up to 30 days]
- length of hospital stay [Time frame: after surgery until hospital discahrge, assessed up to 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- Mackay memorial hospital — Taipei
Identifiers
NCT: NCT06137547 · 20220800015