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

Children's Hospital of Philadelphia (CHOP)

Status and phase: Terminated; Phase 2

Conditions: Low Blood Pressure; End Stage Renal Disease; Intradialytic Hypotension

Treatments: Device: ITD; Device: Sham

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00576524

2007-12-5712

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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2 participants in 2 patient groups

Sham Device first, ITD next

Experimental group

Description:

Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days.

Treatment:

Device: Sham

Device: ITD

ITD first, sham device next

Experimental group

Description:

Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days.

Treatment:

Device: Sham

Device: ITD