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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

December 17, 2007
January 22, 2013
September 2008
February 2011   (final data collection date for primary outcome measure)
Fluid Removal [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Fluid removed as percentage of dry body weight.
The primary efficacy outcome measure will be the fluid removed, the safety outcome measure will be incidence of coomplications, and the device tolerance will be the difference in Breathing Difficulty Index. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00576524 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Secondary outcome measures include: the number of extra days requried for dialysis/ultrafiltration to acheive target dry weight, differences in hematocrit measured by the Crit-Line. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Changes in heart rate and blood pressure measured by a non-invasive cuff. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis
Application of Impedance Threshold Device Technologies to Treat and Prevent Intradialytic Hypotension in Children Undergoing Hemodialysis

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Intradialytic Hypotension
  • End Stage Renal Disease
  • Low Blood Pressure
  • 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: Sham Device first, ITD next
    Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days.
    Interventions:
    • Device: ITD
    • Device: Sham
  • Experimental: ITD first, sham device next
    Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days.
    Interventions:
    • Device: ITD
    • Device: Sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00576524
2007-12-5712
No
Vijay Srinivasan, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Advanced Circulatory Systems
Principal Investigator: Vijay Srinivasan, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP