Early Ultrafiltration for Patients Initiating Hemodialysis

About This Grant

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.