NCT05010941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 11, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

August 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2022

Completed
Last Updated

May 5, 2022

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

August 11, 2021

Last Update Submit

May 4, 2022

Conditions

Living Donor Liver TransplantationHypotension

Outcome Measures

Primary Outcomes (1)

  • Prediction of Hypotension 5 Minutes Before the Event

    Receiver operating characteristic curve for the Hypotension Prediction Index, Comparison of the hypotensive event and the Hypotension Prediction Index 5 minutes before the event

    During the surgery

Secondary Outcomes (2)

  • Prediction of Hypotension 10 Minutes Before the Event

    During the surgery

  • Prediction of Hypotension 15 Minutes Before the Event

    During the surgery

Study Arms (1)

Hypotension prediction index

prediction of hypotension events

Device: Hypotension Prediction Index

Interventions

Hypotension Prediction IndexDEVICE

Hypotension Prediction Index monitored via radial arterial line

Hypotension prediction index

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing living donor liver transplantation

You may qualify if:

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

You may not qualify if:

  • Patients with arrhythmia or pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (13)

  • Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.

    PMID: 19934864BACKGROUND

  • 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.

    PMID: 26083768BACKGROUND

  • Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.

    PMID: 26181335BACKGROUND

  • Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.

    PMID: 23835589BACKGROUND

  • Davies SJ, Vistisen ST, Jian Z, Hatib F, Scheeren TWL. Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients. Anesth Analg. 2020 Feb;130(2):352-359. doi: 10.1213/ANE.0000000000004121.

    PMID: 30896602BACKGROUND

  • Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.

    PMID: 32065827BACKGROUND

  • 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.

    PMID: 32960954BACKGROUND

  • 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.

    PMID: 28974066BACKGROUND

  • 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.

    PMID: 29894315BACKGROUND

  • Moller S, Christensen E, Henriksen JH. Continuous blood pressure monitoring in cirrhosis. Relations to splanchnic and systemic haemodynamics. J Hepatol. 1997 Aug;27(2):284-94. doi: 10.1016/s0168-8278(97)80173-0.

    PMID: 9288602BACKGROUND

  • Avolio AP, Van Bortel LM, Boutouyrie P, Cockcroft JR, McEniery CM, Protogerou AD, Roman MJ, Safar ME, Segers P, Smulyan H. Role of pulse pressure amplification in arterial hypertension: experts' opinion and review of the data. Hypertension. 2009 Aug;54(2):375-83. doi: 10.1161/HYPERTENSIONAHA.109.134379. Epub 2009 Jun 29. No abstract available.

    PMID: 19564542BACKGROUND

  • 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.

    PMID: 33446404BACKGROUND

  • 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.

    PMID: 29367620BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Hee Soo Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 18, 2021

Study Start

August 13, 2021

Primary Completion

March 12, 2022

Study Completion

March 12, 2022

Last Updated

May 5, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)