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

Study Overview
=================
Brief 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).

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

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

Intervention / Treatment
-----------------
* Device: Accuryn Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed or Verbal Informed Consent as required by IRB (if applicable). Adult (age ≥ 18). Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment). Patient is undergoing cardiac surgical intervention(s). Exclusion Criteria: 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
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 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CABG, Acute Kidney Injury (AKI), Cardiovascular Surgery, Intraabdominal Pressure (IAP), Urine Output (UO), Accuryn