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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-10

Study Completion Date

2019-11-05

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.

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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.

Conditions

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Acute Kidney Injury Abdominal Compartment Syndrome Intraabdominal Hypertension Cardiovascular Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Accuryn Monitoring System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No