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: Recruiting

Administrative data

• NCT number: NCT04669548
• Other study ID #: CRD-06-101904
• Status: Recruiting
• Start date: December 21, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2022
• Source: Potrero Medical
• Contact: Bev Ann Blackwell
• Phone: 256-679-5422
• Email: bblackwell[@]potreromed.com
• Is FDA regulated: No
• Study type: Observational

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 cardiac surgical intervention(s).

The secondary objective is to determine the incidence of intraoperative and postoperative intra-abdominal hypertension in the cardiovascular surgery population, analyze what factors may contribute to the development of intra-abdominal hypertension (IAH) in this patient population, and analyze associations of IAH with organ dysfunctions such as acute kidney injury and other clinical outcomes (e.g. ICU length of stay, required hemodialysis, readmission).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed or Verbal Informed Consent as required by IRB (if applicable).

2. Adult (age = 18).

3. Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).

4. Patient is undergoing cardiac surgical intervention(s).

Exclusion Criteria:

1. Known history of advanced chronic kidney disease defined by an estimated glomerular filtration rate (eGFR) <20 mL/min/1.73m2 within 30 days prior to procedure.

2. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as pregnant women, 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	Mission Health Hospital	Asheville	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Hospital	Durham	North Carolina
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Jewish Hospital / University of Louisville	Louisville	Kentucky
United States	San Francisco VA Medical Center	San Francisco	California
United States	George Washington University Hospital	Washington	District of Columbia
United States	Cleveland Clinic Florida	Weston	Florida
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

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 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