Monitoring physiologic signals in cardiovascular surgery patients
Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)
This study is testing whether monitoring certain health signals during heart surgery can help doctors understand and prevent kidney problems and high pressure in the abdomen in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Potrero Medical Industry-sponsored |
| Locations | 9 sites (Los Angeles, California and 8 other locations) |
| Trial ID | NCT04669548 on ClinicalTrials.gov |
What this trial studies
The Accuryn Registry collects and analyzes physiologic data from patients undergoing cardiovascular surgery using the Accuryn Monitoring System. This observational study aims to correlate changes in these data streams with the occurrence of acute kidney injury (AKI) and assess the incidence of intra-abdominal hypertension in this population. By utilizing both retrospective and prospective data collection methods, the study seeks to identify factors contributing to intra-abdominal hypertension and its association with organ dysfunctions. The findings may help improve patient outcomes in cardiac surgical interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing cardiac surgical interventions and are monitored using the Accuryn Monitoring System.
Not a fit: Patients with advanced chronic kidney disease or those deemed unsuitable by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring and management of acute kidney injury and intra-abdominal hypertension in cardiovascular surgery patients.
How similar studies have performed: Other studies have shown promise in using monitoring systems to track physiologic changes in surgical patients, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 8 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Active_not_recruiting)
- San Francisco VA Medical Center — San Francisco, California, United States (Terminated)
- George Washington University Hospital — Washington D.C., District of Columbia, United States (Recruiting)
- Cleveland Clinic Florida — Weston, Florida, United States (Recruiting)
- Jewish Hospital / University of Louisville — Louisville, Kentucky, United States (Recruiting)
- Mission Health Hospital — Asheville, North Carolina, United States (Recruiting)
- Duke University Hospital — Durham, North Carolina, United States (Recruiting)
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Active_not_recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Bev Ann Blackwell
- Email: bblackwell@potreromed.com
- Phone: 256-679-5422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.