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

Completed

• Conditions: Intraabdominal Hypertension; Cardiovascular Surgery; Abdominal Compartment Syndrome; Acute Kidney Injury
• Interventions: Device: Accuryn Monitoring System

• Registration Number: NCT04585555
• Lead Sponsor: Potrero Medical

Brief 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.

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 Timeline

• Study Start: 2017-07-10
• Primary Completion: 2019-10-06
• Study Completion: 2019-11-05
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Accuryn Monitoring System	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.

Primary Outcome Measures

Name	Time	Method
Intra-Abdominal Pressure (IAP)	30 days	Intra-Abdominal Pressure (mmHg) trending while on a urinary catheter, as well as active measurements taken by clinician
Temperature (T)	30 days	Temperature (degrees Celsius) trending during hospital stay
Abdominal Compartment Syndrome (ACS)	30 days	Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration)
Urine Output (UO)	30 days	High accuracy Urine Output (mL/hour) while on a urinary catheter, and estimated UO while not on a urinary catheter
Intraabdominal Hypertension (IAH)	30 days	Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration)
Acute Kidney Injury (AKI)	30 days	% of patients diagnosed with AKI, and hospitalization day of diagnosis. AKI diagnosed per KDIGO criteria (Stage 1 to 3)

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States