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

This study has been terminated.

(Completion not feasible. THERE ARE NO RESULTS FROM THIS TRIAL)

Sponsor:

Collaborator:

Advanced Circulatory Systems

Information provided by (Responsible Party):

Vijay Srinivasan, Children's Hospital of Philadelphia

ClinicalTrials.gov Identifier:

NCT00576524

First received: December 17, 2007

Last updated: January 22, 2013

Last verified: January 2013

History of Changes

Purpose

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	Intervention	Phase
Intradialytic Hypotension End Stage Renal Disease Low Blood Pressure	Device: ITD Device: Sham	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Low Blood Pressure

U.S. FDA Resources

Further study details as provided by Vijay Srinivasan, Children's Hospital of Philadelphia:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	2
Study Start Date:	September 2008
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576524

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


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
Study First Received:	December 17, 2007
Results First Received:	December 12, 2012
Last Updated:	January 22, 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 Renal Insufficiency, Chronic Hypotension	Urologic Diseases Renal Insufficiency Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 28, 2017

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