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

End Stage Renal Disease Clinical Trial

— ITD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00576524
• Other study ID #: 2007-12-5712
• Status: Terminated
• Phase: Phase 2
• First received: December 17, 2007
• Last updated: January 22, 2013
• Start date: September 2008
• Est. completion date: February 2011

Study information

• Verified date: January 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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.

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

Intervention

Device:
• ITD
ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
• Sham
Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Advanced Circulatory Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid Removal	Fluid removed as percentage of dry body weight.	6 weeks	Yes
Secondary	Extra Days to Achieve Target Dry Weight	Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight	6 weeks	No
Secondary	Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.		6 weeks	Yes