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NCT04669548Recruiting

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

Potrero Medical

Start Date

12/21/2020

Completion Date

12/31/2026

Summary

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.

Detailed Description

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

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Accuryn Monitoring System

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Conditions

Intraabdominal HypertensionAbdominal Compartment SyndromeAcute Kidney InjuryCardiovascular Surgery

Locations

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

San Francisco VA Medical Center

San Francisco, California 94121

United States

George Washington University Hospital

Washington D.C., District of Columbia 20037

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

Jewish Hospital / University of Louisville

Louisville, Kentucky 40202

United States

Mission Health Hospital

Asheville, North Carolina 28803

United States

Duke University Hospital

Durham, North Carolina 27710

United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina 27157

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States