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Trial record 2 of 15 for:    Potrero

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

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ClinicalTrials.gov Identifier: NCT04669548
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
Potrero Medical

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
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).

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Study Type : Observational
Estimated 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 : December 21, 2020
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. Temperature (T) [ Time Frame: 30 days ]
    Temperature (degrees Celsius) trending during hospital stay

  4. Intraabdominal Hypertension (IAH) [ Time Frame: 30 days ]
    Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration)

  5. 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)

  6. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669548


Contacts
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Contact: Bev Ann Blackwell 256-679-5422 bblackwell@potreromed.com
Contact: Ariane Marcus 888-635-7280 amarcus@potreromed.com

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Manxu Zhao, MD    310-423-5841    manxu.zhao@cshs.org   
Principal Investigator: Manxu Zhao, MD         
San Francisco VA Medical Center Active, not recruiting
San Francisco, California, United States, 94121
United States, District of Columbia
George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Gage Parr, MD    202-715-4000    KPARR@mfa.gwu.edu   
Principal Investigator: Gage Parr, MD         
United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Steven Minear, MD    954-290-1569    minears@ccf.org   
Contact: Camila Teixeira, MD    954-909-1025    decarvc@ccf.org   
Principal Investigator: Steven Minear, MD         
United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Madhav Swaminathan, MD    919-681-6532    madhav.swaminathan@duke.edu   
Principal Investigator: Madhav Swaminathan, MD         
Wake Forest Baptist Medical Center Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Michael Kot, MD    216-442-6616    kotm@ccf.org   
Principal Investigator: Michael Kot, MD         
Sponsors and Collaborators
Potrero Medical
Investigators
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Study Director: Vanessa Moll, MD, PhD Potrero Medical
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Responsible Party: Potrero Medical
ClinicalTrials.gov Identifier: NCT04669548    
Other Study ID Numbers: CRD-06-101904
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Potrero Medical:
Acute Kidney Injury (AKI)
CABG
Cardiovascular Surgery
Intraabdominal Pressure (IAP)
Urine Output (UO)
Accuryn
Additional relevant MeSH terms:
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Compartment Syndromes
Intra-Abdominal Hypertension
Acute Kidney Injury
Vascular Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Muscular Diseases
Musculoskeletal Diseases