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NCT Number: NCT06137547

HPI for Prevention of Hypotension During Cardiac Surgery

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.

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Key information

Conditions

Cardiac Surgery Patients Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mackay memorial hospital

Taipei, 104, Taiwan

Location status: Recruiting

Location contact

Yingchun Lin, Master

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypotension prediction index (HPI)

Device

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.

Primary outcomes

  1. 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)

    Time-weighted average of intraoperative hypotension below 65 mmHg

Secondary outcomes

  1. incidence of hypotension

    Time frame: from induction to the end of surgery (excluding CPB time)

  2. duration of hypotension

    Time frame: from induction to the end of surgery (excluding CPB time)

  3. postoperative complications

    Time frame: 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

  4. length of ICU stay

    Time frame: after surgery until ICU discharge, assessed up to 30 days

  5. length of hospital stay

    Time frame: after surgery until hospital discahrge, assessed up to 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Ying-Chun Lin, Master

CONTACT

[email protected]

+886-02-25433535 ext. 3009

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

Hypotension Prediction Index for Prevention of Hypotension During Cardiac Surgery: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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