Clinical trial NCT00576524: Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis
Official title: Application of Impedance Threshold Device Technologies to Treat and Prevent Intradialytic Hypotension in Children Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Intradialytic Hypotension
End Stage Renal Disease
Low Blood Pressure
Keywords: Hypotension during dialysis
End Stage Renal Disease
Decrease complications during dialysis
Low Blood Pressure
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Advanced Circulatory Systems
First posted: 2007-12-19
Enrollment: 2
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fluid Removal
timeFrame: 6 weeks
Secondary outcomes:
measure: Extra Days to Achieve Target Dry Weight
timeFrame: 6 weeks
measure: Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Vijay Srinivasan, MD
role: PRINCIPAL_INVESTIGATOR
References: