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Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

NCT04669548 · Potrero Medical
In plain English

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Official title
Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)
About this study
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).
Eligibility criteria
Inclusion Criteria: 1. Signed or Verbal Informed Consent as required by IRB (if applicable). 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: 1. Known history of advanced chronic kidney disease defined by an estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73m2 within 30 days prior to procedure. 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.
Study design
Enrollment target: 2500 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-12-21
Estimated completion: 2026-12-31
Last updated: 2022-09-28
Interventions
Device: Accuryn Monitoring System
Primary outcomes
  • Urine Output (UO) (30 days)
  • Intra-Abdominal Pressure (IAP) (30 days)
  • Temperature (T) (30 days)
Sponsor
Potrero Medical · industry
Contacts & investigators
ContactBev Ann Blackwell · contact · bblackwell@potreromed.com · 256-679-5422
ContactAriane Marcus · contact · amarcus@potreromed.com · 888-635-7280
InvestigatorVanessa Moll, MD, PhD · study_director, Potrero Medical
All locations (9)
Cedars-Sinai Medical CenterActive Not Recruiting
Los Angeles, California, United States
San Francisco VA Medical CenterTerminated
San Francisco, California, United States
George Washington University HospitalRecruiting
Washington D.C., District of Columbia, United States
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
Jewish Hospital / University of LouisvilleRecruiting
Louisville, Kentucky, United States
Mission Health HospitalRecruiting
Asheville, North Carolina, United States
Duke University HospitalRecruiting
Durham, North Carolina, United States
Wake Forest Baptist Medical CenterActive Not Recruiting
Winston-Salem, North Carolina, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry · TrialPath