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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Intradialytic Hypotension; End Stage Renal Disease; Low Blood Pressure	Device: ITD; Device: Sham	Phase 2

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Application of Impedance Threshold Device Technologies to Treat and Prevent Intradialytic Hypotension in Children Undergoing Hemodialysis
Study Start Date :	September 2008
Actual Primary Completion Date :	February 2011
Actual Study Completion Date :	February 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Sham Device first, ITD next; Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days.	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; Other Name: ResQpod Device: 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
Experimental: ITD first, sham device next; Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days.	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; Other Name: ResQpod Device: 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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Fluid Removal [ Time Frame: 6 weeks ]
   Fluid removed as percentage of dry body weight.

Secondary Outcome Measures :

1. Extra Days to Achieve Target Dry Weight [ Time Frame: 6 weeks ]
   Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight
2. Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff. [ Time Frame: 6 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	8 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

Advanced Circulatory Systems

Investigators

Principal Investigator:	Vijay Srinivasan, MD	Children's Hospital of Philadelphia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Vijay Srinivasan, Attending Physician, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00576524 History of Changes
Other Study ID Numbers:	2007-12-5712
First Posted:	December 19, 2007
Results First Posted:	February 26, 2013
Last Update Posted:	February 26, 2013
Last Verified:	January 2013

Keywords provided by Vijay Srinivasan, Children's Hospital of Philadelphia:

Hypotension during dialysis; End Stage Renal Disease; Decrease complications during dialysis; Low Blood Pressure

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Hypotension; Urologic Diseases	Renal Insufficiency, Chronic; Renal Insufficiency; Vascular Diseases; Cardiovascular Diseases