Back to resultsHypotension Prediction Index in Patients Undergoing Liver Transplantation
Primary Purpose
Intraoperative Hypotension
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acumen HPI-enabled EV1000 screen
Sponsored by
About this trial
This is an interventional diagnostic trial for Intraoperative Hypotension
Eligibility Criteria
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
Sites / Locations
- Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acumen HPI-enabled EV1000 screen
Arm Description
Acumen HPI-enabled EV1000 screen
Outcomes
Primary Outcome Measures
Accurate hypotension prediction of EV1000 system
Analyze the actual incidence of hypotension after HPI alarm more than 85 within 15 min
Incidence of intraoperative hypotension
Frequency, duration of intraoperative hypotension, which defined as MAP < 65 mmHg at least 1 min
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
Secondary Outcome Measures
Hospital stay and ICU stay
The incidence and severity of intraoperative hypotension correlate with patient's hospital stay and ICU stay
Mortality after surgery
The incidence and severity of intraoperative hypotension correlate with patient's mortality
Adverse effects
The incidence and severity of hypotension correlate with the adverse effects like acute liver failure, acute kidney injury and acute myocardial injury
Full Information
NCT ID
NCT04872504
First Posted
April 26, 2021
Last Updated
May 3, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04872504
Brief Title
Hypotension Prediction Index in Patients Undergoing Liver Transplantation
Official Title
Performance of the Hypotension Prediction Index With Invasive Arterial Pressure Waveform in Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Hypotension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acumen HPI-enabled EV1000 screen
Arm Type
Experimental
Arm Description
Acumen HPI-enabled EV1000 screen
Intervention Type
Device
Intervention Name(s)
Acumen HPI-enabled EV1000 screen
Intervention Description
Acumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension
Primary Outcome Measure Information:
Title
Accurate hypotension prediction of EV1000 system
Description
Analyze the actual incidence of hypotension after HPI alarm more than 85 within 15 min
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.
Title
Incidence of intraoperative hypotension
Description
Frequency, duration of intraoperative hypotension, which defined as MAP < 65 mmHg at least 1 min
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
Title
Severity of intraoperative hypotension
Description
MAP measurements were recorded every 20 s by the EV1000 system from induction to Time-weighted average mean arterial pressure (TWA-MAP) < 65 mmHg
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
Secondary Outcome Measure Information:
Title
Hospital stay and ICU stay
Description
The incidence and severity of intraoperative hypotension correlate with patient's hospital stay and ICU stay
Time Frame
Days from admission to discharge, assessed up to 1 month
Title
Mortality after surgery
Description
The incidence and severity of intraoperative hypotension correlate with patient's mortality
Time Frame
Days from admission to discharge, assessed up to 1 month
Title
Adverse effects
Description
The incidence and severity of hypotension correlate with the adverse effects like acute liver failure, acute kidney injury and acute myocardial injury
Time Frame
Days from admission to discharge, assessed up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BO HAN YEH
Phone
+886978989006
Email
100311047@gms.tcu.edu.tw
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung Fong Tsai, PHD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hypotension Prediction Index in Patients Undergoing Liver Transplantation
We'll reach out to this number within 24 hrs