NIDDK - National Institute of Diabetes and Digestive and Kidney Diseases
More than 430,000 Americans receive maintenance hemodialysis treatments for end stage kidney disease. The health of the dialysis population remains sub-optimal: five-year survival for patients initiating in-center hemodialysis is only 42% with a course marked by frequent hospitalizations and debilitating symptoms. A major deficiency of prevailing intermittent dialysis treatments is the inability to control extracellular volume. Ongoing volume overload is present in >65% of patients receiving maintenance hemodialysis treatments. Residual volume overload promotes a vicious cycle of resistant hypertension, cardiac dysfunction, pulmonary congestion, and activity-limiting symptoms. Attempts to reduce extracellular volume with intermittent dialysis treatments are beset by hypotension and symptoms caused by overly rapid rates of ultrafiltration that exceed vascular refilling and the pervasive use of anti-hypertensive medications. Historical studies using frequent slow dialysis treatments and concomitant tapering of blood pressure medications achieved normotension without use of medications in >95% of patients. The intensive dialysis protocols used in these historical studies would be difficult to implement today. However, an abbreviated adaptation could yield clinically important and sustained benefits and be acceptable to providers and payers. We propose a randomized trial to test the effects of two concentrated ultrafiltration strategies in hemodialysis patients who have clinical suspicion of ongoing volume excess. Patients will be assigned to either usual dialysis care, a 4-week ultrafiltration strategy, or an 8-week ultrafiltration strategy. Each strategy will add two extra ultrafiltration treatments per week plus guided tapering of blood pressure medications to achieve blood pressures <130/80 mmHg without use of medications, unless prescribed for a non-blood pressure indication. Following the intervention periods, participants will return to usual dialysis care. We will test whether the concentrated ultrafiltration strategies are associated with sustained improvements in 24-hour ambulatory blood pressure, symptoms of congestion, medication use, and six-minute walk distance. In parallel, we will test whether these strategies are associated with more favorable hemodynamic responses to intermittent dialysis treatments, fewer symptoms of dialysis-related fatigue, and fewer episodes of intra-dialytic hypotension.
Up to $774K
2030-11-30
Detailed requirements not yet analyzed
Have the NOFO? Paste it below for AI-powered requirement analysis.
One-time $749 fee · Includes AI drafting + templates + PDF export
Dynamic Cognitive Phenotypes for Prediction of Mental Health Outcomes in Serious Mental Illness
NIMH - National Institute of Mental Health — up to $18.3M
Leveraging Artificial Intelligence to Predict Mental Health Risk among Youth Presenting to Rural Primary Care Clinics
NIMH - National Institute of Mental Health — up to $15.0M
Feasibility of Genomic Newborn Screening Through Public Health Laboratories
OD - NIH Office of the Director — up to $14.4M
WOMEN'S HEALTH INITIATIVE (WHI) CLINICAL COORDINATING CENTER - TASK AREA A AND A2
NHLBI - National Heart Lung and Blood Institute — up to $10.2M
Metal Exposures, Omics, and AD/ADRD risk in Diverse US Adults
NIA - National Institute on Aging — up to $10.2M
NHLBI CATALYZE PRECLINICAL SERVICES: PROJECTS YR. 4 - TASK ORDER 5
NHLBI - National Heart Lung and Blood Institute — up to $10.0M