Hypotension Prediction Index in Patients Undergoing Liver Transplantation

Overview

A prospective, open-label and single-center study to determine whether the use of Acumen Hypotension Prediction Index software predicts the occurrence of hypotension.

Full Title of Study: “Performance of the Hypotension Prediction Index With Invasive Arterial Pressure Waveform in Liver Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2024

Interventions

  • Device: Acumen HPI-enabled EV1000 screen
    • Acumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension

Arms, Groups and Cohorts

  • Experimental: Acumen HPI-enabled EV1000 screen
    • Acumen HPI-enabled EV1000 screen

Clinical Trial Outcome Measures

Primary Measures

  • Accurate hypotension prediction of EV1000 system
    • Time Frame: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day.
    • Analyze the actual incidence of hypotension after HPI alarm more than 85 within 15 min
  • Incidence of intraoperative hypotension
    • Time Frame: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day
    • Frequency, duration of intraoperative hypotension, which defined as MAP < 65 mmHg at least 1 min
  • Severity of intraoperative hypotension
    • Time Frame: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day
    • MAP measurements were recorded every 20 s by the EV1000 system from induction to Time-weighted average mean arterial pressure (TWA-MAP) < 65 mmHg

Secondary Measures

  • Hospital stay and ICU stay
    • Time Frame: Days from admission to discharge, assessed up to 1 month
    • The incidence and severity of intraoperative hypotension correlate with patient’s hospital stay and ICU stay
  • Mortality after surgery
    • Time Frame: Days from admission to discharge, assessed up to 1 month
    • The incidence and severity of intraoperative hypotension correlate with patient’s mortality
  • Adverse effects
    • Time Frame: Days from admission to discharge, assessed up to 1 month
    • The incidence and severity of hypotension correlate with the adverse effects like acute liver failure, acute kidney injury and acute myocardial injury

Participating in This Clinical Trial

Inclusion Criteria

  • Written informed consent – Age ≥ 20 years; – Scheduled liver transplantation – Planned pressure monitoring with an arterial line; – General anesthesia Exclusion Criteria:

  • Contraindication for invasive blood pressure monitoring – End-staged renal disease – pre-operative MAP <65 mmHg – Severe heart failure – Severe cardiac shunt – Severe aortic stenosis – Severe atrial fibrillation

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chang Gung Memorial Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • BO HAN YEH, +886978989006, 100311047@gms.tcu.edu.tw

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