Hypotension Prediction Index in Living Donor Liver Transplantation

Completed

• Conditions: Living Donor Liver Transplantation; Hypotension
• Interventions: Device: Hypotension Prediction Index

• Registration Number: NCT05010941
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The Hypotension Prediction Index via the Edwards Hemosphere advanced monitoring system is monitored in living donor liver transplantation recipients. The Hypotension Prediction Index is analyzed to verify the performance in predicting hypotensive events.

Detailed Description

Hypotensive events during surgery and anesthesia occur frequently and are associated with complications such as myocardial infarction, acute kidney injury, and increase in mortality. Therefore predicting and preventing hypotension can lead to better outcomes.

The Hypotension Prediction Index is monitored with the Edwards Hemosphere advanced monitoring system in living donor liver transplantation recipients via the radial artery. The monitor is blinded so that the anesthesiologist cannot see the index, and the anesthesiologist manages the blood pressure according to the institution's anesthetic protocol for liver transplantation. After the surgery is done, the Hypotension Prediction Index is analyzed to see how well the index predicted actual hypotension that occured during the liver transplantation surgery. Receiver operating characteristic curves are drawn to show the performance of the Hypotension Prediction Index in liver transplantation.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-11
• Study Start: 2021-08-13
• Study First Posted: 2021-08-18
• Primary Completion: 2022-03-12
• Study Completion: 2022-03-12
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients scheduled for living donor liver transplantation aged 20 years and older
• Patients who understand the trial and have given informed consent

Exclusion Criteria

• Patients with arrhythmia or pacemaker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypotension prediction index	Hypotension Prediction Index	prediction of hypotension events

Primary Outcome Measures

Name	Time	Method
Prediction of Hypotension 5 Minutes Before the Event	During the surgery	Receiver operating characteristic curve for the Hypotension Prediction Index, Comparison of the hypotensive event and the Hypotension Prediction Index 5 minutes before the event

Secondary Outcome Measures

Name	Time	Method
Prediction of Hypotension 15 Minutes Before the Event	During the surgery	Receiver operating characteristic curve for the Hypotension Prediction Index, Comparison of the hypotensive event and the Hypotension Prediction Index 15 minutes before the event
Prediction of Hypotension 10 Minutes Before the Event	During the surgery	Receiver operating characteristic curve for the Hypotension Prediction Index, Comparison of the hypotensive event and the Hypotension Prediction Index 10 minutes before the event

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of