Intra-abdominal hypertension in cardiac surgery patients: a multicenter observational sub-study of the Accuryn registry.
Ashish K Khanna, Steven Minear, Andrea Kurz...
https://pubmed.ncbi.nlm.nih.gov/35695943Actively Recruiting
Age: 18Years +
All Genders
ID04669548
Physiologic Signals and Signatures With the Accuryn Monitoring System A Retrospective and Prospective Analysis (The Accuryn Registry)
Led by Potrero Medical · Updated on 2022-09-28
2500
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to track and analyze physiological data from patients undergoing cardiovascular surgery using the Accuryn Monitoring System, a device cleared by the FDA. The study focuses on monitoring changes in vital signs to understand their relationship with acute kidney injury (AKI) after cardiac surgery. Additionally, it seeks to explore how intra-abdominal hypertension (IAH) develops during and after surgery and its association with organ dysfunction and clinical outcomes like ICU stay length and need for hemodialysis. Participants in this study are cardiovascular surgery patients monitored using the Accuryn Monitoring System, which is a novel Foley catheter with built-in sensors that continuously and non-invasively collect high-frequency data on vital signs. The study is observational and includes both retrospective and prospective data collection during the patients' hospital stay, particularly throughout their surgical procedure and ICU admission. During the study, researchers collect physiological data such as urine output, intra-abdominal pressure, temperature, and occurrences of intra-abdominal hypertension, abdominal compartment syndrome, and acute kidney injury for up to 30 days. The data come from electronic medical records and the monitoring system. Participants' typical care continues without intervention, and the study helps researchers better understand important clinical outcomes related to cardiovascular surgery.
CONDITIONS
Brief Title
Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed or verbal informed consent as required by the IRB
- Age 18 years or older
- Monitored on the Accuryn Monitoring System during procedure and ICU stay (for retrospective enrollment)
- Undergoing cardiac surgical intervention(s)
You will not qualify if you...
- Known advanced chronic kidney disease with estimated glomerular filtration rate below 20 mL/min/1.73m2 within 30 days before procedure
- Considered unsuitable for the study by the investigator, including vulnerable populations such as pregnant women or prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 30 days
Participants undergoing cardiovascular surgical interventions are observed with the Accuryn Monitoring System during their hospital stay to continuously capture physiologic data.
Continuous monitoring during hospital stay
Trial Site Locations
Total: 9 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Active, Not Recruiting
2
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Terminated
3
George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
4
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
5
Jewish Hospital / University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
Mission Health Hospital
Asheville, North Carolina, United States, 28803
Actively Recruiting
7
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Active, Not Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
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Research Team
B
Bev Ann Blackwell
A
Ariane Marcus
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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