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

Potrero Medical50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Kidney Injury Abdominal Compartment Syndrome Intraabdominal Hypertension Cardiovascular Surgery

Interventions

Accuryn Monitoring SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult (age ≥ 18). 2. Monitored on the Accuryn® Monitoring System during hospital stay. 3. 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.

Locations (1)

Emory University Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Urine 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

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

Data from ClinicalTrials.gov

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