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).
Study Type
OBSERVATIONAL
Enrollment
2,500
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.
Cedars-Sinai Medical Center
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGSan Francisco VA Medical Center
San Francisco, California, United States
TERMINATEDGeorge Washington University Hospital
Washington D.C., District of Columbia, United States
RECRUITINGCleveland Clinic Florida
Weston, Florida, United States
RECRUITINGJewish Hospital / University of Louisville
Louisville, Kentucky, United States
RECRUITINGMission Health Hospital
Asheville, North Carolina, United States
RECRUITINGDuke University Hospital
Durham, North Carolina, United States
RECRUITINGWake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
ACTIVE_NOT_RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGUrine Output (UO)
High accuracy Urine Output (mL/hour) while on a urinary catheter, and estimated UO while not on a urinary catheter
Time frame: 30 days
Intra-Abdominal Pressure (IAP)
Intra-Abdominal Pressure (mmHg) trending while on a urinary catheter, as well as active measurements taken by clinician clinician
Time frame: 30 days
Temperature (T)
Temperature (degrees Celsius) trending during hospital stay
Time frame: 30 days
Intraabdominal Hypertension (IAH)
Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration)
Time frame: 30 days
Abdominal Compartment Syndrome (ACS)
Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration)
Time frame: 30 days
Acute Kidney Injury (AKI)
% of patients diagnosed with AKI, and hospitalization day of diagnosis. AKI diagnosed per KDIGO criteria (Stage 1 to 3)
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.