Kidney Health Initiative (KHI)

KHI Workgroup Opportunity

Fostering Innovation in Fluid Management

Summary

Achievement of optimal salt and water balance after dialysis is a primary goal of 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. There are numerous barriers to developing fluid management devices:

  • Lack of uniform terminology and definitions when discussing fluid management
  • Lack of gold standards for volume assessment by which to compare and validate new products
  • Lack of product testing and validation in dialysis patients, a population often with high burdens of comorbidity and poor nutrition (factors that may impact body composition assessment)
  • Lack of communication among developers in the space (learn from failures and successes)
  • Focus on in-center technologies (blood volume monitoring, bio-impedance) versus technologies more in-line with patients' desires to be home with more independence and a better quality of life (e.g. wearables, sensors, miniaturization)
  • Lack of clinical trial data showing that improved fluid management improves outcomes

Advances in fluid assessment would have ramifications for populations beyond hemodialysis patients. Volume status assessment and management affects individuals on peritoneal dialysis and individuals with kidney transplants and chronic kidney disease as well as individuals with heart failure, liver disease and those with critical illness.

Project

This project is divided into two phases which will be completed sequentially.

Phase 1 has the following objectives:

  • Identify aspects of fluid management of significant importance to individuals with chronic kidney disease (pre-end-stage kidney disease, hemodialysis, peritoneal dialysis and transplant) that may be modifiable through medical device interventions
  • Develop standardized terminology and definitions for fluid management to facilitate fluid assessment and management standards development

Phase 2 has the following objecives

  • Create a catalogue of existing and devices in development that have potential relevance to fluid management
  • Conduct a needs assessment for fluid assessment and management devices to identify gaps in innovation
  • Develop design criteria and specific research activities needed for fluid assessment and management devices
  • Work with Centers for Medicare and Medicaid Services (CMS) to identify and develop potential payment programs that would allow dialysis providers to incorporate fluid management devices and programs into patient treatment programs.

In order to achieve these goals, we will first assemble a workgroup of key stakeholders drawing from the diverse membership of the Kidney Health Initiative:

  • Academic researchers
  • Dialysis providers
  • Patients
  • Device manufacturers
  • Government (FDA, CMS)

The deliverables of Phase 1 will be:

  • Summary of prioritized needs for patient fluid assessment and management
  • Standardized definitions and terminology for fluid assessment and management

The deliverable for Phase 2 will be:

  • Inventory of devices available and in-development that may be applicable to fluid assessment and management
  • Needs assessment and gap analysis for devices for fluid assessment and management
  • Design criteria (minimal acceptable requirements) and specific research activities for the development of fluid assessment and management devices
  • Guidance from CMS on potential reimbursement pathways for fluid assessment and management devices

Workgroup Role and Responsibility

The charge of the workgroup includes:

  • Conduct patient research activities to identify patient needs for patient fluid assessment and management
  • Convene scientific, industry and regulatory experts to develop standardized terminology and definitions in the field of fluid management
  • Conduct primary and secondary research to identify devices available and in-development that may be applicable to fluid assessment and management
  • Analyze data from primary and secondary research to develop a needs assessment, gap analysis and design criteria for devices for fluid assessment and management
  • Engage in discussions with CMS on potential reimbursement pathways for fluid assessment and management devices
Estimated Time Commitment

Workgroup members will be asked to participate in regular conference calls or webinars (ideally no more than twice per month) and respond to emails in a timely manner. In-person planning or working meetings will be determined by the project plan. This is a volunteer position and compensation will not be offered for participation.

Goal for completion of the Phase 1 is 9-12 months with the project kicking off in June, 2018. Phase 2 will commence immediately following completion of Phase 1 and be completed in 9-12 months.

Recommended Expertise
  • Direct experience and/or expertise with fluid assessment and management
  • Relevant expertise and ability to represent at least 1 of the following stakeholder groups on the project: Publication.
    • Dialysis providers
    • Academic researchers
    • Industry
    • Patients
    • Research groups
    • Additional groups and organizations that are essential to this area
Application and Deadline

Friday, July 6, 2018

All interested candidates should apply to serve on this workgroup. The application can be sent to khi@asn-online.org.
with a subject line of "Workgroup: Fluid Management". Please include the following information in your email:

  1. Name and contact information
  2. CV or resume
  3. Reason for wanting to participate in this workgroup (no more than 250 words)
  4. Explanation of how you will contribute to the project (no more than 250 words)
  5. Your interest in being the chair of the workgroup, a member or both

All applicants need to have an updated a disclosure form on file here.

Mailing List

If you are interested in the topic, but not in serving on the workgroup, please email khi@asn-online.org.
and KHI staff will send more information as available.

If you have any questions, please do not hesitate to contact KHI at khi@asn-online.org.

Selected 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. McIntyre CW, Goldsmith DJ: Ischemic brain injury in hemodialysis patients: which is more dangerous, hypertension or intradialytic hypotension? Kidney Int 2015, 87(6):1109-1115.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.