An observational study in Intraabdominal Hypertension, Abdominal Compartment Syndrome and Acute Kidney Injury, sponsored by Potrero Medical. Recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Potrero Medical · Observational
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.
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).
75 studies on the registry are indexed under Compartment Syndromes; 12 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 110 across 30 observational studies indexed under Compartment Syndromes.
Browse Compartment Syndromes studies →Potrero Medical is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Urine Output (UO)
High accuracy Urine Output (mL/hour) while on a urinary catheter, and estimated UO while not on a urinary catheter
Time frame: 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
Time frame: 30 days
Temperature (T)
Temperature (degrees Celsius) trending during hospital stay
Time frame: 30 days
Intraabdominal Hypertension (IAH)
Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration)
Time frame: 30 days
Abdominal Compartment Syndrome (ACS)
Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration)
Time frame: 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)
Time frame: 30 days
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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