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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Abdominal Compartment Syndrome; Intraabdominal Hypertension; Cardiovascular Surgery
• Intervention / Treatment: Device: 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 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 (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Accuryn Monitoring System; 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.

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	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

Collaborators and Investigators

• Sponsor: Potrero Medical
• Investigators: Principal Investigator: Amit Prabhakar, MD, Emory University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2017
• Primary Completion (ACTUAL): October 6, 2019
• Study Completion (ACTUAL): November 5, 2019

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Musculoskeletal Diseases; Muscular Diseases; Acute Kidney Injury; Compartment Syndromes; Intra-Abdominal Hypertension
• Other Study ID Numbers: CRD-06-2963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes