Physiologic Signals and Signatures With the Accuryn Monitoring System (The Accuryn Registry)
1 other identifier
observational
50
1 country
1
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 P25-P50 for all trials
Started Jul 2017
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
July 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2019
CompletedFirst Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedFebruary 4, 2021
February 1, 2021
2.2 years
August 21, 2020
February 2, 2021
Conditions
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
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) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay.
You may qualify if:
- Adult (age ≥ 18).
- Monitored on the Accuryn® Monitoring System during hospital stay.
- Patient is undergoing cardiovascular surgical intervention(s).
You may not qualify if:
- \. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as prisoners or those detained in a penal institution.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Potrero Medicallead
Study Sites (1)
Emory University Hospital
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Prabhakar, MD
Emory University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
October 14, 2020
Study Start
July 10, 2017
Primary Completion
October 6, 2019
Study Completion
November 5, 2019
Last Updated
February 4, 2021
Record last verified: 2021-02