Hypotension Prediction Index in Patients Undergoing Liver Transplantation
Performance of the Hypotension Prediction Index With Invasive Arterial Pressure Waveform in Liver Transplantation
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedMay 4, 2021
April 1, 2021
2.8 years
April 26, 2021
May 3, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Hospital stay and ICU stay
Days from admission to discharge, assessed up to 1 month
Mortality after surgery
Days from admission to discharge, assessed up to 1 month
Adverse effects
Days from admission to discharge, assessed up to 1 month
Study Arms (1)
Acumen HPI-enabled EV1000 screen
EXPERIMENTALAcumen HPI-enabled EV1000 screen
Interventions
Acumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension
Eligibility Criteria
You may qualify if:
- Written informed consent
- Age ≥ 20 years;
- Scheduled liver transplantation
- Planned pressure monitoring with an arterial line;
- General anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2021
First Posted
May 4, 2021
Study Start
May 1, 2021
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
May 4, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share