Real-Time Urine Flow Rate Measurement: Interview with Christopher Strafaci, VP of Sales and Marketing at RenalSense


Fluid overload is a serious issue for critically ill patients. It can occur in a variety of situations, including as a result of acute kidney injury, and can also be an issue in critically ill COVID-19 patients. The condition requires prompt treatment to restore health fluid levels, and Medgadget recently featured an interview with CHF Solutions CEO John Erb about the Aquadex Ultrafiltration system, which is designed to safely restore fluid levels as an alternative to dialysis.  

Monitoring urine flow is crucial in assessing fluid overload and in making treatment decisions. At present, urine flow is typically assessed by nurses, who simply look at the urine drainage bag of a patient to determine the urine flow rate. However, this method is crude and time consuming.

CHF solutions recently signed a distribution agreement with RenalSense, a renal diagnostics company based in Israel and Massachusetts, to sell the ClarityRMS urine flow real-time monitoring system. The system consists of an electronic sensor that connects to a catheter and provides healthcare staff with real-time information on urine flow. This approach avoids the staff time and potential for human error of current urine flow rate assessment techniques.      

Medgadget had the opportunity to talk to Christopher Strafaci, RenalSense Vice President of Sales and Marketing, North America, about this technology.

Conn Hastings, Medgadget: Please give us an overview of fluid overload and the risks it poses, particularly for patients with COVID-19.

Christopher Strafaci, RenalSense: Fluid overload occurs when excess fluid — primarily salt and water — builds up throughout the body. It’s often referred to as volume overload or hypervolemia and when left untreated, it can create major issues among critically ill children and adults.

We typically see fluid overload in patients with heart failure or kidney disorders such as acute kidney injury (AKI), and in critical care patients. Fluid retention also happens when the liver is failing and after surgeries that require IV fluids. Many critically ill COVID-19 patients experience AKI that results in decreased urinary output and fluid overload, and this sudden episode of kidney failure can lead to multi-organ failure and death if it isn’t quickly treated. Fifty-seven percent of ICU patients develop AKI, and ICU patients with AKI have a mortality rate that is five times higher than patients without AKI. Quickly identifying fluid overload and subsequently treating it is absolutely critical for effective patient care.

Medgadget: How is fluid overload typically identified at present? Is it easy to identify before it causes problems?

Christopher Strafaci: The signs and symptoms of fluid overload can include rapid weight gain and swelling in the arms, legs, face and abdomen, high blood pressure, shortness of breath, and pleural effusion, which is an accumulation of fluid in the space that surrounds the lungs. Since fluid overload is common after surgeries and in people with kidney, heart and liver failure, physicians typically keep an eye on it, although typical measurement methods are limited. In cases where the kidneys quickly begin to fail, such as patients with AKI or trauma, problems can quickly unravel. It’s important that fluid overload is quickly identified and treated to prevent disease progression.

Real-time monitoring of urine flow can appropriately reflect changes in renal function so that providers can identify the best treatment strategy. When you can pair easy and insightful diagnostics with efficient and predictable treatment methods such as ultrafiltration to remove excess fluid, the patient can receive timely care that can help improve outcomes and avoid adverse events.

Medgadget: Please give us an overview of the Clarity Real-Time Monitoring System.

Christopher Strafaci: RenalSense’s Clarity RMS is a critical care monitoring system that continuously measures urine flow and automatically transmits real-time data and notification of fluctuations to medical staff on a 24/7 basis. Traditionally, urine output is measured manually by a nurse through a patient’s urine drainage bag. This manual approach is extremely time consuming and prone to human error. Clarity RMS addresses the shortcomings of manual urine flow monitoring by automatically measuring output and notifying clinicians of suboptimal urine flow rate based on certain criteria. With this information, providers have real-time data to inform treatment strategies that can be paired with a treatment designed to alleviate kidney burden and fluid overload complications. RenalSense recently partnered with CHF Solutions to offer the Clarity RMS diagnostic tool alongside its Aquadex SmartFlow ultrafiltration therapy. When suboptimal fluid output indicates fluid overload, Aquadex can be used to safely remove excess fluid from the body. The therapy was developed with the goal of being more flexible and gentle on the kidneys than dialysis. Physicians can specify and adjust the exact amount and rate of fluid to be removed from each patient, resulting in gradual fluid balance.

Medgadget: How does the system transmit notifications about urine output and fluid overload to caregivers?

Christopher Strafaci: The system has an electronic sensor that easily connects to a Foley catheter where it continuously and reliably measures fluctuations in urine flow. The Intelligent Notification System then notifies the medical team when the urine flow rate falls below globally accepted standards. The battery-powered bedside monitor continuously calculates and is capable of transmitting real-time data from the sensor directly to all hospital information systems. This allows the medical team to identify changes in kidney function earlier and adjust treatment rapidly. 

Medgadget: How does the system minimize the risk of complications?

Christopher Strafaci: Just like in many other disease management tools, early intervention saves lives. When clinicians and medical teams are quickly alerted of issues that would otherwise likely be overlooked, treatment strategies can be initiated immediately to effectively care for the patients. The system is a complementary diagnostic tool to therapeutic technologies like the Aquadex SmartFlow system. RenalSense is excited to expand the distribution of Clarity RMS through its partnership with CHF Solutions and equally thrilled to offer providers two systems that can truly improve outcomes for people suffering from fluid overload while also improving provider workflow.

Medgadget: How will this latest distribution deal help to increase the reach of the Clarity RMS?

Christopher Strafaci: The distribution deal between RenalSense and CHF Solutions will help more hospitals in certain US territories gain access to automatic, real-time data monitoring for renal function. A patient’s fluid balance is a critical vital sign, and urine output and fluid status should be electronically monitored in the same way other vital signs are monitored in the OR and ICU. This partnership will make it easier for health systems to use technology to expediently diagnose and treat fluid overload before it creates a dangerous situation for the patient.

Link: RenalSense homepage…

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