Physiologic Signals and Signatures With the Accuryn Monitoring System (The Accuryn Registry)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)

Conditions
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Acute Kidney Injury, Abdominal Compartment Syndrome, Intraabdominal Hypertension, Cardiovascular Surgery

Intervention / Treatment
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* Device: Accuryn Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (age ≥ 18). Monitored on the Accuryn® Monitoring System during hospital stay. Patient is undergoing cardiovascular surgical intervention(s). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Accuryn Monitoring System<br>Observational only (no intervention). Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay. | Device: Accuryn Monitoring System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |