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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585555
• Other study ID #: CRD-06-2963
• Status: Completed
• Start date: July 10, 2017
• Est. completion date: November 5, 2019

Study information

• Verified date: February 2021
• Source: Potrero Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 5, 2019
• Est. primary completion date: October 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Compartment Syndrome
• Acute Kidney Injury
• Cardiovascular Surgery
• Compartment Syndromes
• Intra-Abdominal Hypertension
• Intraabdominal Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Potrero Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Intra-Abdominal Pressure (IAP)	Intra-Abdominal Pressure (mmHg) trending while on a urinary catheter, as well as active measurements taken by clinician	30 days
Primary	Temperature (T)	Temperature (degrees Celsius) trending during hospital stay	30 days
Primary	Intraabdominal Hypertension (IAH)	Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration)	30 days
Primary	Abdominal Compartment Syndrome (ACS)	Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration)	30 days
Primary	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