Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
NCT ID: NCT04669548
Last Updated: 2022-09-28
Study Results
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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RECRUITING
2500 participants
OBSERVATIONAL
2020-12-21
2026-12-31
Brief Summary
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Detailed Description
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The secondary objective is to determine the incidence of intraoperative and postoperative intra-abdominal hypertension in the cardiovascular surgery population, analyze what factors may contribute to the development of intra-abdominal hypertension (IAH) in this patient population, and analyze associations of IAH with organ dysfunctions such as acute kidney injury and other clinical outcomes (e.g. ICU length of stay, required hemodialysis, readmission).
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Accuryn Monitoring System
Observational only (no intervention). Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay
Accuryn Monitoring System
The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.
Interventions
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Accuryn Monitoring System
The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.
Eligibility Criteria
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Inclusion Criteria
2. Adult (age ≥ 18).
3. Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).
4. Patient is undergoing cardiac surgical intervention(s).
Exclusion Criteria
2. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as pregnant women, prisoners ,or those detained in a penal institution.
18 Years
ALL
No
Sponsors
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Potrero Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Vanessa Moll, MD, PhD
Role: STUDY_DIRECTOR
Potrero Medical
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
San Francisco VA Medical Center
San Francisco, California, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Cleveland Clinic Florida
Weston, Florida, United States
Jewish Hospital / University of Louisville
Louisville, Kentucky, United States
Mission Health Hospital
Asheville, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Khanna AK, Minear S, Kurz A, Moll V, Stanton K, Essakalli L, Prabhakar A; Predict AKI Group. Intra-abdominal hypertension in cardiac surgery patients: a multicenter observational sub-study of the Accuryn registry. J Clin Monit Comput. 2023 Feb;37(1):189-199. doi: 10.1007/s10877-022-00878-2. Epub 2022 Jun 13.
Other Identifiers
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CRD-06-101904
Identifier Type: -
Identifier Source: org_study_id
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