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

Phase 2

Terminated

Conditions: Intradialytic Hypotension
End Stage Renal Disease
Low Blood Pressure

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Sham Device first, ITD next	ITD	Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days.
Sham Device first, ITD next	Sham	Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days.
ITD first, sham device next	ITD	Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days.
ITD first, sham device next	Sham	Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days.

Primary Outcome Measures

Name	Time	Method
Fluid Removal	6 weeks	Fluid removed as percentage of dry body weight.

Secondary Outcome Measures

Name	Time	Method
Extra Days to Achieve Target Dry Weight	6 weeks	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.	6 weeks