KHI Current Project

Fostering Innovation in Fluid Management

Abstract

Achievement of optimal salt and water balance after dialysis is a primary goal of renal replacement therapy (RRT). Inadequate fluid management leads to significant morbidity and mortality from complications of hypervolemia and hypovolemia. We lack technologies to accurately assess volume status. Therefore, the clinical approach to volume assessment is subjective and involves trial and error. Insufficient innovation in the fluid management space over the last two decades, provides a clear need to stimulate innovation and collaboration across stakeholders in that arena. KHI is uniquely positioned to forge these collaborations. We believe improving fluid management will substantially improve patient clinical and patient-reported outcomes.

Deliverables

A document that outlines the technical design requirements of an ideal, future device to help patients and/or clinicians manage a person's fluid before, during, after and in between dialysis treatments.

Timeline

Completion goal of Summer 2019

"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.[6] 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.[9]

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

Role Name Organization
Co-ChairDerek ForfangNational Kidney Foundation
Co-ChairYossi Chait, MS, PhDUniversity of Massachusetts Amherst
MemberGwen Derk University of Illinois Urbana-Champaign
MemberNathan Gooch, PhDBecton Dickinson (BD)
MemberBarbara A. Greco, MDTufts University School of Medicine
MemberTzu-Jen Kao, MD, PhDGE Global Research
MemberConall O'Seaghdha, MRCPIpatientMpower
MemberErinn S. ReillyFAST BioMedical
MemberJesse RoachCenters for Medicare and Medicaid Services
MemberAmy J. Steig, PhDGraftWorx
MemberIsaac Teitelbaum, MD, FACPUniversity of Colorado Denver
MemberCaroline WilkieKHI Patient & Family Partnership
MemberKenneth R. Wilund, PhDUniversity of Illinois Urbana-Champaign
Board of Directors LiaisonJennifer Flythe, MPH, MD, FASNUNC School of Medicine
Staff LiaisonMeaghan AllainKidney Health Initiative

References

  1. 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.
  2. 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.
  3. 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.
  4. McIntyre CW, Odudu A: Hemodialysis-associated cardiomyopathy: a newly defined disease entity. Semin Dial 2014, 27(2):87-97.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.