Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
1 other identifier
observational
2,500
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedStudy Start
First participant enrolled
December 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
September 28, 2022
September 1, 2022
6 years
December 9, 2020
September 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Urine Output (UO)
High accuracy Urine Output (mL/hour) while on a urinary catheter, and estimated UO while not on a urinary catheter
30 days
Intra-Abdominal Pressure (IAP)
Intra-Abdominal Pressure (mmHg) trending while on a urinary catheter, as well as active measurements taken by clinician clinician
30 days
Temperature (T)
Temperature (degrees Celsius) trending during hospital stay
30 days
Intraabdominal Hypertension (IAH)
Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration)
30 days
Abdominal Compartment Syndrome (ACS)
Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration)
30 days
Acute Kidney Injury (AKI)
% of patients diagnosed with AKI, and hospitalization day of diagnosis. AKI diagnosed per KDIGO criteria (Stage 1 to 3)
30 days
Study Arms (1)
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
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.
Eligibility Criteria
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.
You may qualify if:
- Signed or Verbal Informed Consent as required by IRB (if applicable).
- Adult (age ≥ 18).
- Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).
- Patient is undergoing cardiac surgical intervention(s).
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Potrero Medicallead
Study Sites (9)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
San Francisco VA Medical Center
San Francisco, California, 94121, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Jewish Hospital / University of Louisville
Louisville, Kentucky, 40202, United States
Mission Health Hospital
Asheville, North Carolina, 28803, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
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.
PMID: 35695943DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vanessa Moll, MD, PhD
Potrero Medical
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2020
First Posted
December 17, 2020
Study Start
December 21, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
September 28, 2022
Record last verified: 2022-09