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

September 26, 2022 updated by: Potrero Medical

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Active, not recruiting
        • Cedars-Sinai Medical Center
      • San Francisco, California, United States, 94121
        • Terminated
        • San Francisco VA Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • George Washington University Hospital
        • Contact:
    • Florida
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida
        • Contact:
    • Kentucky
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Hospital
        • Contact:
        • Principal Investigator:
          • Madhav Swaminathan, MD
      • Winston-Salem, North Carolina, United States, 27157
        • Active, not recruiting
        • Wake Forest Baptist Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Michael Kot, MD
          • Phone Number: 216-442-6616
          • Email: kotm@ccf.org
        • Principal Investigator:
          • Michael Kot, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cardiovascular surgical intervention(s) who meet eligibility criteria and are monitored with the Accuryn Monitoring System throughout their procedure and intensive care unit (ICU) stay.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Potrero Medical

Investigators

  • Study Director: Vanessa Moll, MD, PhD, Potrero Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

December 9, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD-06-101904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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