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

NCT ID: NCT04669548

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-21

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Intraabdominal Hypertension Abdominal Compartment Syndrome Acute Kidney Injury Cardiovascular Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Accuryn Monitoring System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Potrero Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanessa Moll, MD, PhD

Role: STUDY_DIRECTOR

Potrero Medical

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status ACTIVE_NOT_RECRUITING

San Francisco VA Medical Center

San Francisco, California, United States

Site Status TERMINATED

George Washington University Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Cleveland Clinic Florida

Weston, Florida, United States

Site Status RECRUITING

Jewish Hospital / University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

Mission Health Hospital

Asheville, North Carolina, United States

Site Status RECRUITING

Duke University Hospital

Durham, North Carolina, United States

Site Status RECRUITING

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bev Ann Blackwell

Role: CONTACT

256-679-5422

Ariane Marcus

Role: CONTACT

888-635-7280

Facility Contacts

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Gage Parr, MD

Role: primary

202-715-4000

Steven Minear, MD

Role: primary

954-290-1569

Camila Teixeira, MD

Role: backup

954-909-1025

Terry Blanton, BSN, RN

Role: primary

502-587-4381

Shavonne Silvers, LPN

Role: backup

5026815171

Leslie McPeters, MSN, FNP

Role: primary

828-213-5679

Lynne Hampton, MBA, RN

Role: backup

828.213.5631

Madhav Swaminathan, MD

Role: primary

919-681-6532

Michael Kot, MD

Role: primary

216-442-6616

References

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Khanna AK, Minear S, Kurz A, Moll V, Stanton K, Essakalli L, Prabhakar A; Predict AKI Group. Intra-abdominal hypertension in cardiac surgery patients: a multicenter observational sub-study of the Accuryn registry. J Clin Monit Comput. 2023 Feb;37(1):189-199. doi: 10.1007/s10877-022-00878-2. Epub 2022 Jun 13.

Reference Type DERIVED
PMID: 35695943 (View on PubMed)

Other Identifiers

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CRD-06-101904

Identifier Type: -

Identifier Source: org_study_id

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