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

End Stage Renal Disease Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hypotension
• Intradialytic Hypotension
• Kidney Diseases
• Kidney Failure, Chronic
• Low Blood Pressure

• NCT number: NCT00576524
• Study type: Interventional
• Source: Children's Hospital of Philadelphia
• Status: Terminated
• Phase: Phase 2
• Start date: September 2008
• Completion date: February 2011