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

Study Overview
=================
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.

Official Title
-----------------
Application of Impedance Threshold Device Technologies to Treat and Prevent Intradialytic Hypotension in Children Undergoing Hemodialysis

Conditions
-----------------
End Stage Renal Disease, Intradialytic Hypotension, Low Blood Pressure

Intervention / Treatment
-----------------
* Device: ITD
* Device: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sham Device first, ITD next<br>Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days. | Device: ITD<br>* ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions<br>* Other names: ResQpod;Device: Sham<br>* Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions<br>|
| Experimental: ITD first, sham device next<br>Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days. | Device: ITD<br>* ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions<br>* Other names: ResQpod;Device: Sham<br>* Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid Removal | Fluid removed as percentage of dry body weight. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extra Days to Achieve Target Dry Weight | Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight | 6 weeks | 
| Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff. |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypotension during dialysis, End Stage Renal Disease, Decrease complications during dialysis, Low Blood Pressure