Fostering Innovation in Fluid Management
Today's innovators can change the status quo in fluid management for people with kidney failure. For people with kidney failure, a critical function of renal replacement therapy is maintaining volume balance through fluid management. Too much or too little volume can result in significant complications, including morbidity and mortality. Despite the potential for severe complications, current fluid management methods amount to trial and error, and there are no approved devices for objectively measuring volume status.
The Kidney Health Initiative has released a supplement to its RRT Technology Roadmap titled Fostering Innovation in Fluid Management. This document provides guidance to spur innovation in fluid management devices and techniques that will improve the quality of life of people with kidney failure.Fostering Innovation in Fluid Management
"Denying yourself a cold glass of water is the worst. Everywhere you look, as a dialysis patient, you see beverages: water, ice, sodas, coffee, tea, slushies,… did I say water?" -51-year-old woman on hemodialysis
Achieving the optimal fluid balance with dialysis is extremely difficult. When too much fluid is removed or fluid is removed too quickly, cramps and fatigue often occur. When too little fluid is removed or if patients have too large of weight gains between treatments, bloating, shortness of breath and fatigue often occur. Knowing how much fluid to remove is a huge challenge and is far from a precise science. Such adverse clinical sequelae of imprecise fluid management have substantial impact on long-term clinical and patient-reported outcomes. Chronic volume overload, clinical or subclinical, is associated with increased hospitalizations and mortality. Hypovolemia, either due to inaccurate dry weight estimation or overly rapid fluid removal during dialysis, is associated with clinical and subclinical end-organ ischemia that can lead to long-term organ damage and dysfunction.[2-5, 7, 8] These fluid-related challenges are associated not only with substantial patient morbidity and mortality, but also with high health care system utilization and costs.
One of the most challenging issues for dialysis patients and their healthcare providers is accurately determining an individual's ideal weight (dry/target weight). Despite all the technological and engineering advances in medicine over the last several decades, there has been surprisingly little innovation when it comes to volume status estimation. Devices such as non-invasive blood volume monitoring, bioimpedance and lung ultrasound have shown some promise. However, there is currently no FDA-approved device for body weight/composition determination. This is a critical gap in care that has vast implications for patient quality of life and clinical outcomes.
Inspired by advances in glucose monitoring and fitness tracking, this project challenges the community to consider innovations that might involve wearables devices with real-time feedback so patients can adjust their behaviors in response to fluid status as well as other innovative technologies that move us away from dependence on in-clinic monitoring devices.
- Summarize patient priorities
- Standardize definitions and terminology
- Catalogue existing and under-development relevant technologies with needs assessment
- Produce a guide and stimulate device innovation in fluid management
|Co-Chair||Derek Forfang||National Kidney Foundation|
|Co-Chair||Yossi Chait, MS, PhD||University of Massachusetts Amherst|
|Member||Gwen Derk||University of Illinois Urbana-Champaign|
|Member||Nathan Gooch, PhD||Becton Dickinson (BD)|
|Member||Barbara A. Greco, MD||Tufts University School of Medicine|
|Member||Tzu-Jen Kao, MD, PhD||GE Global Research|
|Member||Conall O'Seaghdha, MRCPI||patientMpower|
|Member||Erinn S. Reilly||FAST BioMedical|
|Member||Jesse Roach||Centers for Medicare and Medicaid Services|
|Member||Amy J. Steig, PhD||GraftWorx|
|Member||Isaac Teitelbaum, MD, FACP||University of Colorado Denver|
|Member||Caroline Wilkie||KHI Patient & Family Partnership|
|Member||Kenneth R. Wilund, PhD||University of Illinois Urbana-Champaign|
|Board of Directors Liaison||Jennifer Flythe, MPH, MD, FASN||UNC School of Medicine|
|Staff Liaison||Juanita Rogers||Kidney Health Initiative|
- Flythe JE, Kshirsagar AV, Falk RJ, Brunelli SM: Associations of Posthemodialysis Weights above and below Target Weight with All-Cause and Cardiovascular Mortality. Clin J Am Soc Nephrol 2015 2015, 10(5):808-16.
- Burton JO, Jefferies HJ, Selby NM, McIntyre CW: Hemodialysis-induced repetitive myocardial injury results in global and segmental reduction in systolic cardiac function. Clin J Am Soc Nephrol 2009, 4(12):1925-1931.
- McIntyre CW, Harrison LE, Eldehni MT, Jefferies HJ, Szeto CC, John SG, Sigrist MK, Burton JO, Hothi D, Korsheed S et al: Circulating endotoxemia: a novel factor in systemic inflammation and cardiovascular disease in chronic kidney disease. Clin J Am Soc Nephrol 2011, 6(1):133-141.
- McIntyre CW, Odudu A: Hemodialysis-associated cardiomyopathy: a newly defined disease entity. Semin Dial 2014, 27(2):87-97.
- Hecking M, Karaboyas A, Antlanger M, Saran R, Wizemann V, Chazot C, Rayner H, Hörl WH, Pisoni RL, Robinson BM et al: Significance of interdialytic weight gain versus chronic volume overload: consensus opinion. Am J Nephrol 2013, 38(1):78-90.
- Flythe JE, Kimmel SE, Brunelli SM: Rapid fluid removal during dialysis is associated with cardiovascular morbidity and mortality. Kidney Int 2011, 79(2):250-257.
- Flythe JE, Xue H, Lynch KE, Curhan GC, Brunelli SM: Association of mortality risk with various definitions of intradialytic hypotension. J Am Soc Nephrol 2015, 26(3):724-734.
- Arneson TJ, Liu J, Qiu Y, Gilbertson DT, Foley RN, Collins AJ: Hospital treatment for fluid overload in the Medicare hemodialysis population. Clin J Am Soc Nephrol 2010, 5(6):1054-1063.
- Perl J, Dember LM, Bargman JM, Browne T, Charytan DM, Flythe JE, Hickson LJ, Hung AM, Jadoul M, Lee TC et al: The Use of a Multidimensional Measure of Dialysis Adequacy-Moving beyond Small Solute Kinetics. Clin J Am Soc Nephrol March 17, 2017. Epub ahead of print.
- Weiner DE, Brunelli SM, Hunt A, Schiller B, Glassock R, Maddux FW, Johnson D, Parker T, Nissenson A: Improving Clinical Outcomes Among Hemodialysis Patients: A Proposal for a "Volume First" Approach From the Chief Medical Officers of US Dialysis Providers. Am J Kidney Dis 2014, 2014 Nov;64(5):685-95.