Recruiting

Accuryn Monitoring

Sponsor:

Potrero Medical

Code:

NCT04669548

Conditions

Intraabdominal Hypertension

Abdominal Compartment Syndrome

Acute Kidney Injury

Cardiovascular Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Accuryn Monitoring System

Study Details

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.

Conditions

Intraabdominal Hypertension

Abdominal Compartment Syndrome

Acute Kidney Injury

Cardiovascular Surgery

Study ID

NCT04669548

Start date

Dec 21, 2020

Status verified date

Sep, 2022

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • Urine Output (UO) [ Time Frame: 30 days ]
  • Intra-Abdominal Pressure (IAP) [ Time Frame: 30 days ]
  • Temperature (T) [ Time Frame: 30 days ]
  • Intraabdominal Hypertension (IAH) [ Time Frame: 30 days ]
  • Abdominal Compartment Syndrome (ACS) [ Time Frame: 30 days ]
  • Acute Kidney Injury (AKI) [ Time Frame: 30 days ]

Central Contacts and Locations

Locations

George Washington University Hospital

Recruiting

Washington, District of Columbia, United States, 20037

Contacts

Principal Investigator:

Gage Parr, MD

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Contacts

Principal Investigator:

Steven Minear, MD

Jewish Hospital / University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Jiapeng Huang, MD, PhD

Mission Health Hospital

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Principal Investigator:

Mark Groh, MD

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Madhav Swaminathan, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Michael Kot, MD

More Information

Sponsor

Potrero Medical

Last update posted

Sep 28, 2022

Last verified

Sep, 2022

Keywords

  • Acute Kidney Injury (AKI)
  • CABG
  • Cardiovascular Surgery
  • Intraabdominal Pressure (IAP)
  • Urine Output (UO)
  • Accuryn

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Potrero Medical on 2022-09-28.