Application of Impedance Threshold Device Technologies to Treat and Prevent Intradialytic Hypotension in Children Undergoing Hemodialysis
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Fluid Removal
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sham Device first, ITD next
Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days.
Intervention: ITD (Device)
Sham Device first, ITD next
Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days.
Intervention: Sham (Device)
ITD first, sham device next
Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days.
Intervention: ITD (Device)
ITD first, sham device next
Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days.
Intervention: Sham (Device)
Outcomes
Primary Outcomes
Fluid Removal
Time Frame: 6 weeks
Fluid removed as percentage of dry body weight.
Secondary Outcomes
- Extra Days to Achieve Target Dry Weight(6 weeks)
- Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.(6 weeks)
Investigators
Vijay Srinivasan
Attending Physician
Children's Hospital of Philadelphia