Hypotension Prediction Index in Patients Undergoing Liver Transplantation

Intraoperative Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04872504
• Other study ID #: Hypotension prediction index
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2021
• Source: Chang Gung Memorial Hospital
• Contact: BO HAN YEH
• Phone: +886978989006
• Email: 100311047[@]gms.tcu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension

Intervention

Device:
• Acumen HPI-enabled EV1000 screen
Acumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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	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
Secondary	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
Secondary	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