Accuryn Monitoring System for Cardiac Surgery

Recruiting at 8 trial locations

Overseen By Bev Ann Blackwell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Potrero Medical

Disqualifiers: Advanced chronic kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to collect information from patients who have undergone heart surgery using the Accuryn Monitoring System. The goal is to gather data on patients' bodily responses during and after surgery. This information could help improve care for future heart surgery patients. Individuals who recently had heart surgery and were monitored with the Accuryn System during their hospital stay are ideal candidates for this trial. As an unphased trial, this study offers patients the opportunity to contribute valuable insights that could enhance heart surgery outcomes for others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Accuryn Monitoring System is safe for cardiovascular surgery patients?

Research has shown that the Accuryn Monitoring System is FDA-approved, indicating its safety in certain situations. It monitors key body signals, such as urine output and temperature, in patients during and after heart surgery. The system aims to detect kidney problems early by continuously checking urine output.

Past studies have shown that patients have responded positively to the Accuryn System. As a closed system, it reduces the risk of infections, such as urinary tract infections (UTIs), by limiting exposure to germs, making it safer than systems that are not closed.

Overall, evidence suggests that the Accuryn Monitoring System is safe for patients undergoing heart surgery, providing doctors with crucial information without adding extra risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Accuryn Monitoring System because it offers a new way to closely track patients undergoing cardiovascular surgeries. Unlike traditional monitoring methods, Accuryn provides real-time data on vital parameters like fluid levels and organ function right at the bedside. This continuous and precise monitoring could lead to quicker interventions, potentially improving patient outcomes during their hospital stay. By enhancing the standard of care with advanced technology, the Accuryn system aims to set a new benchmark in patient monitoring.

What evidence suggests that the Accuryn Monitoring System is effective for cardiovascular surgery patients?

Research has shown that the Accuryn Monitoring System, used to monitor participants in this trial, effectively detects acute kidney injury (AKI) early in patients undergoing heart surgery. In a study involving over 500 patients, the system identified AKI 33 hours earlier than standard methods that assess kidney function through blood tests. Early detection of AKI can lead to better treatment and outcomes. Additionally, the system tracks abdominal pressure, which is crucial for managing high abdominal pressure and potentially enhancing patient care in the intensive care unit (ICU). Therefore, strong evidence supports the Accuryn Monitoring System as a valuable tool for monitoring and improving care in heart surgery patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Vanessa Moll, MD, PhD

Principal Investigator

Potrero Medical

Are You a Good Fit for This Trial?

Inclusion Criteria

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).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Physiologic data measurements are collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System during their hospital stay

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on outcomes such as acute kidney injury and intra-abdominal hypertension

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Accuryn Monitoring System

How Is the Trial Designed?

Group I: Accuryn Monitoring System Experimental Treatment 1 Intervention

Observational only (no intervention). Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay

Who Is Running the Clinical Trial?

Potrero Medical

Lead Sponsor

Trials

8

Recruited

2,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04585555

Physiologic Signals and Signatures With the Accuryn ... 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 ...

2. biospace.com biospace.com/press-releases/study-published-in-journal-of-cardiothoracic-and-vascular-anesthesia-finds-accuryn-monitoring-system-detects-acute-kidney-injury-aki-in-cardiac-surgery-patients-33-hours-earlier-than-standard-serum-creatine-criteria

Study Published in Journal of Cardiothoracic and Vascular ... "We're really pleased this study of over 500 patients confirms that the Accuryn Monitoring System can help detect acute kidney injury (AKI) ...

3. accuryn.com accuryn.com/resources/accuryn-clinical-summary/

Accuryn Clinical Evidence Summary The Accuryn Monitoring System transforms ... Comprehensive IAH/ACS management strategies that include IAP monitoring deliver improved outcomes and results.

4. prnewswire.com prnewswire.com/news-releases/study-published-in-journal-of-cardiothoracic-and-vascular-anesthesia-finds-accuryn-monitoring-system-detects-acute-kidney-injury-aki-in-cardiac-surgery-patients-33-hours-earlier-than-standard-serum-creatine-criteria-302358027.html

Study Published in Journal of Cardiothoracic and Vascular ... "We're really pleased this study of over 500 patients confirms that the Accuryn Monitoring System can help detect acute kidney injury (AKI) ...

5. accuryn.com accuryn.com/clinical-trials/

Clinical Trials The purpose of the study is to associate continuous hemodynamic data in cardiovascular surgery patients with clinical outcomes in the ICU, such as Acute Kidney ...

6. jcvaonline.com jcvaonline.com/article/S1053-0770(24)00396-3/fulltext

Urine Output Alerts for Kidney Injury vs. Serum Creatinine Continuous urine output-based alert identifies cardiac surgery–associated acute kidney injury earlier than serum creatinine.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04669548

Study Details | NCT04669548 | Physiologic Signals and ... The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1053077024003963

Continuous Urine Output Alert for Cardiac Surgery AKI The primary objective of the Accuryn Registry study was to analyze data streams (intra-abdominal pressure [IAP], UO, temperature) recorded by the Accuryn ...

9. accuryn.com accuryn.com/wp-content/uploads/2024/10/Journal-of-Cardiothoracic-and-Vascular-Anesthesia-1.pdf

Journal of Cardiothoracic and Vascular Anesthesia The authors investigated the diagnostic performance of continuous UO, enabled by active drain line clearance based alerts (Accuryn AKI Alert), compared with AKI ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9782014/

Catheter-Associated UTI Study: Novel System & Monitoring Both Accuryn® Systems are entirely closed systems where the actual urinary catheter comes connected to the tubing system, which is further secured through ...