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Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.
The primary objective of the Accuryn Registry Study is to is to track and analyze changes in physiologic data streams using the Accuryn Monitoring System and correlate these changes to the occurrence of acute kidney injury (AKI) following cardiac surgical intervention(s). 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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
December 21, 2020
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
September 28, 2022
2,500
ESTIMATED participants
Accuryn Monitoring System
DEVICE
Lead Sponsor
Potrero Medical
NCT05806645
NCT07472426
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07447791