Hypotension Prediction Index in Patients Undergoing Liver Transplantation

Not Applicable

• Conditions: Intraoperative Hypotension
• Interventions: Device: Acumen HPI-enabled EV1000 screen

• Registration Number: NCT04872504
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-26
• Study Start: 2021-05-01
• Study First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acumen HPI-enabled EV1000 screen	Acumen HPI-enabled EV1000 screen	Acumen HPI-enabled EV1000 screen

Primary Outcome Measures

Name	Time	Method
Accurate hypotension prediction of EV1000 system	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
Severity of intraoperative hypotension	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
Incidence of intraoperative hypotension	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

Secondary Outcome Measures

Name	Time	Method
Hospital stay and ICU stay	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
Adverse effects	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
Mortality after surgery	Days from admission to discharge, assessed up to 1 month	The incidence and severity of intraoperative hypotension correlate with patient's mortality

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan City, Taiwan