Hypotension Prediction Index in Patients Undergoing Liver Transplantation

Performance of the Hypotension Prediction Index With Invasive Arterial Pressure Waveform in Liver Transplantation

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

Study Overview

• Status: Recruiting
• Conditions: Intraoperative Hypotension
• Intervention / Treatment: Device: Acumen HPI-enabled EV1000 screen

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BO HAN YEH; Phone Number: +886978989006; Email: 100311047@gms.tcu.edu.tw

Study Locations

• Taiwan
  • Taoyuan City, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Yung Fong Tsai, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acumen HPI-enabled EV1000 screen	Device: Acumen HPI-enabled EV1000 screen; Acumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: Hypotension prediction index

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes