Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

Sponsor

Potrero Medical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04669548

Collaborator

(none)

2,500

Enrollment

Locations

72.3

Anticipated Duration (Months)

357.1

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraabdominal Hypertension Abdominal Compartment Syndrome Acute Kidney Injury Cardiovascular Surgery	Device: 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 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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

2500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 21, 2020

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
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	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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed or Verbal Informed Consent as required by IRB (if applicable).
Adult (age ≥ 18).
Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).
Patient is undergoing cardiac surgical intervention(s).

Exclusion Criteria:

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	San Francisco VA Medical Center	San Francisco	California	United States	94121
3	George Washington University Hospital	Washington	District of Columbia	United States	20037
4	Cleveland Clinic Florida	Weston	Florida	United States	33331
5	Duke University Hospital	Durham	North Carolina	United States	27710
6	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
7	Cleveland Clinic	Cleveland	Ohio	United States	44195