AzTrials
AzTrials

Living Donor Liver TransplantationNCT05010941

Hypotension Prediction Index in Living Donor Liver Transplantation

An observational study of Living Donor Liver Transplantation and Hypotension, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Hypotension Prediction Index
Type of treatment
Medical device
How many people
20 participants
Where
1 siteSouth Korea
Study dates
13 Aug 2021to 12 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing living donor liver transplantation

Who may be able to join

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

Who cannot join

  • Patients with arrhythmia or pacemaker

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Performance of the Hypotension Prediction Index in Living Donor Liver Transplantation

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.

Read the 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.

Being tested
Hypotension Prediction Index
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypotension Prediction IndexDevice

    Hypotension Prediction Index monitored via radial arterial line

Study groups in NCT05010941
Study groupRoleWhat they receive
Hypotension prediction indexprediction of hypotension events
Receives: Device: Hypotension Prediction Index

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: During the surgery

Secondary outcomes (2)

  1. Prediction of Hypotension 10 Minutes Before the Event

    Receiver operating characteristic curve for the Hypotension Prediction Index, Comparison of the hypotensive event and the Hypotension Prediction Index 10 minutes before the event

    Measured: During the surgery

  2. Prediction of Hypotension 15 Minutes Before the Event

    Receiver operating characteristic curve for the Hypotension Prediction Index, Comparison of the hypotensive event and the Hypotension Prediction Index 15 minutes before the event

    Measured: During the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start13 Aug 2021
  3. Primary completion12 Mar 2022
  4. Study completion12 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010941
Sponsor's protocol ID
2107-228-1240
Status last verified
Aug 2021
First submitted
11 Aug 2021
Last updated
5 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19934864

  • 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.

    PubMed 26083768

  • 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.

    PubMed 26181335

  • 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.

    PubMed 23835589

  • 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.

    PubMed 30896602

  • 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.

    PubMed 32065827

  • 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.

    PubMed 32960954

  • 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.

    PubMed 28974066

  • 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.

    PubMed 29894315

  • 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.

    PubMed 9288602

  • 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.

    PubMed 19564542

  • 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.

    PubMed 33446404

  • 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.

    PubMed 29367620

Questions about this trial

What is this clinical trial studying?

An observational study of Living Donor Liver Transplantation and Hypotension, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prediction of Hypotension 5 Minutes Before the Event (time frame: During the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05010941, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in