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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 cardiovascular surgery intervention(s).
The secondary objective is to determine the incidence of IAH and ACS in the cardiovascular surgery population and the correlation of these diagnoses to the diagnosis of AKI.
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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 | 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:
1. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as prisoners or those detained in a penal institution.
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Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay.
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| Name | Affiliation | Role |
|---|---|---|
| Amit Prabhakar, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 8, 2021 | |
| Reset | May 6, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 8, 2021 | May 6, 2021 |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D059325 | Intra-Abdominal Hypertension |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |