Hypotension Prediction Index in Living Donor Liver Transplantation

NCT ID: NCT05010941

Last Updated: 2022-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-13

Study Completion Date

2022-03-12

Brief Summary

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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

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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.

Conditions

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Living Donor Liver Transplantation Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypotension prediction index

prediction of hypotension events

Hypotension Prediction Index

Intervention Type DEVICE

Hypotension Prediction Index monitored via radial arterial line

Interventions

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Hypotension Prediction Index

Hypotension Prediction Index monitored via radial arterial line

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hee Soo Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Reference Type BACKGROUND
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Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.

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Reference Type BACKGROUND
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Maheshwari K, Shimada T, Yang D, Khanna S, Cywinski JB, Irefin SA, Ayad S, Turan A, Ruetzler K, Qiu Y, Saha P, Mascha EJ, Sessler DI. Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery. Anesthesiology. 2020 Dec 1;133(6):1214-1222. doi: 10.1097/ALN.0000000000003557.

Reference Type BACKGROUND
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Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.

Reference Type BACKGROUND
PMID: 28974066 (View on PubMed)

Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 19564542 (View on PubMed)

Shin B, Maler SA, Reddy K, Fleming NW. Use of the Hypotension Prediction Index During Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jun;35(6):1769-1775. doi: 10.1053/j.jvca.2020.12.025. Epub 2020 Dec 21.

Reference Type BACKGROUND
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Lee HC, Jung CW. Vital Recorder-a free research tool for automatic recording of high-resolution time-synchronised physiological data from multiple anaesthesia devices. Sci Rep. 2018 Jan 24;8(1):1527. doi: 10.1038/s41598-018-20062-4.

Reference Type BACKGROUND
PMID: 29367620 (View on PubMed)

Other Identifiers

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2107-228-1240

Identifier Type: -

Identifier Source: org_study_id

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