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

Potrero Medical

Status: Completed

Conditions: Intraabdominal Hypertension; Acute Kidney Injury; Abdominal Compartment Syndrome; Cardiovascular Surgery

Treatments: Device: Accuryn Monitoring System

Study type: Observational

Funder types: Industry

Identifiers

NCT04585555

CRD-06-2963

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Accuryn Monitoring System

Description:

Observational only (no intervention). Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay.

Treatment:

Device: Accuryn Monitoring System