Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis (ITD)

• Extra Days to Achieve Target Dry Weight [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight
• Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

• Secondary outcome measures include: the number of extra days requried for dialysis/ultrafiltration to acheive target dry weight, differences in hematocrit measured by the Crit-Line. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
• Changes in heart rate and blood pressure measured by a non-invasive cuff. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

The purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.

Effective fluid removal during hemodialysis is one of the biggest challenges in children with end-stage renal disease (ESRD). Generally, children do not tolerate having more than 3-4% of their body weight removed during each dialysis session thus necessitating multiple sessions each week to ensure effective renal replacement. Excessive fluid removal is often associated with nausea, vomiting, hypotension and cramps resulting in serious complications in patient care during and immediately after dialysis as well as reduced patient compliance. The development of novel therapies to increase the amount of fluid removed during each session without a corresponding increase in the incidence of complications is therefore very important to improve quality and compliance with hemodialysis; and eventually survival of children with ESRD. The purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.

• Intradialytic Hypotension
• End Stage Renal Disease
• Low Blood Pressure

• Device: ITD
  ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
  Other Name: ResQpod
• Device: Sham
  Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions

• Experimental: Sham Device first, ITD next
  Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days.
  Interventions:

  • Device: ITD
  • Device: Sham
• Experimental: ITD first, sham device next
  Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days.
  Interventions:

  • Device: ITD
  • Device: Sham

Inclusion Criteria:

• Subjects 8-18 years of age
• Subjects undergoing hemodialysis for ESRD

Exclusion Criteria:

• Subjects less than 8 years old or greater than 18 years old.
• Hemodialysis for indications other than ESRD.
• Current symptoms of chest pain, shortness of breath, fever, presence of dilated cardiomyopathy, unstable congestive heart failure, pulmonary hypertension, atrial fibrillation, hyperthyroidism, and aortic stenosis.