Hypotension Prediction Index in Patients Undergoing Liver Transplantation

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

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

Conditions
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Intraoperative Hypotension

Intervention / Treatment
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* Device: Acumen HPI-enabled EV1000 screen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acumen HPI-enabled EV1000 screen<br>Acumen HPI-enabled EV1000 screen | Device: Acumen HPI-enabled EV1000 screen<br>* Acumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension<br>|

What is the study measuring?
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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 |