- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06654388
To Construct a Prognosis Prediction Model for ECMO Patients Based on Machine Learning Algorithms
Study Overview
Status
Conditions
Detailed Description
Extracorporeal Membrane Oxygenation (ECMO) is used to provide continuous extracorporeal respiratory and circulatory support for patients with severe cardiopulmonary failure. It is the most important life support method in critical care medicine, and also one of the most complex and expensive treatment methods in intensive care unit (ICU). It takes a lot of resources to maintain. Therefore, it is particularly important to strictly grasp the indications of patients and accurately predict the prognosis of patients to assist clinical decision-making.
Several previous published studies have used clinical scores to predict the prognosis of ECMO patients, but most of them focused on ECMO outcomes in specific patient groups, such as adult respiratory distress syndrome(ARDS), respiratory failure, lung transplantation, cardiogenic shock, and so on. In addition, most of these estimates were calculated using traditional statistical methods and have limited fitting power for data sets with more characteristic variables.
Artificial Intelligence (AI) and Machine Learning (ML) provide a more advanced alternative to traditional statistical methods, and have unparalleled advantages in dealing with data sets with high-dimensional characteristic variables and nonlinear data. And it can self-iterate to improve model performance. In addition, ML, which can process information based on causal or statistical data, may reveal hidden dependencies between clinical indicators and disease prognosis and support clinical decision making, has emerged as the best alternative The primary outcome measures discharged alive from the hospital and died during hospitalization. A total of 69 clinical characteristic indicators were identified based on relevant literature and insights from ECMO experts in critical care medicine. These indicators included demographic data such as age, height, weight, and the medical history of ECMO patients. Additionally, infection indicators were assessed within 24 hours prior to the initiation of ECMO support and within 24 hours after its discontinuation. Furthermore, indicators pertaining to cardiac, renal, and hepatic function, as well as the type of shock (distributive shock, hypovolemic shock, cardiogenic shock, obstructive shock), were included. In addition, the average daily liquid volume within three days after the initiation of ECMO support, the duration of ECMO support, and the ICU length of stay were also considered.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Zhujiang Hospital of Southern Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients who underwent ECMO in our hospital and were registered in the CSECLS registry database (ClinicalTrials.gov Identifier:NCT04158479) from January 1, 2018 to now were retrospectively collected.
Exclusion Criteria:
- ECMO was discontinued for non-medical reasons.
- Under 18 years of age.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Death
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Survive
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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survive
Time Frame: Patients were recorded from 48 hours before initiation of ecmo to the date of survival to hospital discharge or death for up to three months
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Patients were recorded from 48 hours before initiation of ecmo to the date of survival to hospital discharge or death for up to three months
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death
Time Frame: Patients were recorded from 48 hours before initiation of ecmo to the date of survival to hospital discharge or death for up to three months
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Patients were recorded from 48 hours before initiation of ecmo to the date of survival to hospital discharge or death for up to three months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ayers B, Wood K, Gosev I, Prasad S. Predicting Survival After Extracorporeal Membrane Oxygenation by Using Machine Learning. Ann Thorac Surg. 2020 Oct;110(4):1193-1200. doi: 10.1016/j.athoracsur.2020.03.128. Epub 2020 May 23.
- Stephens AF, Seman M, Diehl A, Pilcher D, Barbaro RP, Brodie D, Pellegrino V, Kaye DM, Gregory SD, Hodgson C; Extracorporeal Life Support Organization Member Centres. ECMO PAL: using deep neural networks for survival prediction in venoarterial extracorporeal membrane oxygenation. Intensive Care Med. 2023 Sep;49(9):1090-1099. doi: 10.1007/s00134-023-07157-x. Epub 2023 Aug 7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-KY-026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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