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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Fluid Removal [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Fluid removed as percentage of dry body weight.


Secondary Outcome Measures:
  • Extra Days to Achieve Target Dry Weight [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Hypotension during dialysis
End Stage Renal Disease
Decrease complications during dialysis
Low Blood Pressure

Additional relevant MeSH terms:
Hypotension
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases
 Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013