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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05010941
Other study ID # 2107-228-1240
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 13, 2021
Est. completion date March 12, 2022

Study information

Verified date August 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 12, 2022
Est. primary completion date March 12, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Hypotension Prediction Index
Hypotension Prediction Index monitored via radial arterial line

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

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. Review. Erratum in: Hypertension. 2011 Oct;58(4):e30. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Møller 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. — View Citation

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. Erratum in: Anesthesiology. 2016 Mar;124(3):741-2. — View Citation

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. — View Citation

Südfeld 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 During the surgery
Secondary 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 During the surgery
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