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

Last updated: September 26, 2022
Sponsor: Potrero Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Disease

Renal Failure

Cardiac Surgery

Treatment

N/A

Clinical Study ID

NCT04669548
CRD-06-101904
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

Exclusion Criteria:

  1. Known history of advanced chronic kidney disease defined by an estimated glomerularfiltration 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 mayinclude vulnerable patient populations such as pregnant women, prisoners ,or thosedetained in a penal institution.

Study Design

Total Participants: 2500
Study Start date:
December 21, 2020
Estimated Completion Date:
December 31, 2026

Study 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).

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • San Francisco VA Medical Center

    San Francisco, California 94121
    United States

    Terminated

  • George Washington University Hospital

    Washington, District of Columbia 20037
    United States

    Active - Recruiting

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Active - Recruiting

  • Jewish Hospital / University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Mission Health Hospital

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Duke University Hospital

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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