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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accuryn Monitoring System | Observational only (no intervention). Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accuryn Monitoring System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Output (UO) | High accuracy Urine Output (mL/hour) while on a urinary catheter, and estimated UO while not on a urinary catheter | 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 | 30 days |
| Temperature (T) | Temperature (degrees Celsius) trending during hospital stay | 30 days |
| Intraabdominal Hypertension (IAH) | Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration) | 30 days |
| Abdominal Compartment Syndrome (ACS) | Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration) | 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) | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing cardiovascular surgical intervention(s) who meet eligibility criteria and are monitored with the Accuryn Monitoring System throughout their procedure and intensive care unit (ICU) stay.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bev Ann Blackwell | Contact | 256-679-5422 | bblackwell@potreromed.com | |
| Ariane Marcus | Contact | 888-635-7280 | amarcus@potreromed.com |
| Name | Affiliation | Role |
|---|---|---|
| Vanessa Moll, MD, PhD | Potrero Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Active, not recruiting | Los Angeles | California | 90048 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35695943 | Derived | Khanna AK, Minear S, Kurz A, Moll V, Stanton K, Essakalli L, Prabhakar A; Predict AKI Group. Intra-abdominal hypertension in cardiac surgery patients: a multicenter observational sub-study of the Accuryn registry. J Clin Monit Comput. 2023 Feb;37(1):189-199. doi: 10.1007/s10877-022-00878-2. Epub 2022 Jun 13. |
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|
| San Francisco VA Medical Center |
| Terminated |
| San Francisco |
| California |
| 94121 |
| United States |
| George Washington University Hospital | Recruiting | Washington D.C. | District of Columbia | 20037 | United States |
|
| Cleveland Clinic Florida | Recruiting | Weston | Florida | 33331 | United States |
|
| Jewish Hospital / University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
|
| Mission Health Hospital | Recruiting | Asheville | North Carolina | 28803 | United States |
|
| Duke University Hospital | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Wake Forest Baptist Medical Center | Active, not recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| ID | Term |
|---|---|
| D059325 | Intra-Abdominal Hypertension |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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