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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
Results First Received: December 12, 2012  
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
Conditions: Intradialytic Hypotension
End Stage Renal Disease
Low Blood Pressure
Interventions: Device: ITD
Device: Sham

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study recruited subjects from September 2007 to February 2011. The study will be performed in the Dialysis Unit of the Division of Nephrology, Department of Pediatrics at the Children’s Hospital of Philadelphia (CHOP) with informed consent.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study design will consist of a “run-in phase”, followed by a randomized, cross-over, clinical “intervention phase” with application of the ITD (sham or -7 cm H2O) in 20 pediatric subjects undergoing regular hemodialysis.

Reporting Groups
  Description
ITD First, Sham Device Next A group of subjects will be randomized to receive the ITD first, followed by sham 7 days later.
Sham Device First, ITD Next A group of subjects will be randomized to receive sham first, followed by ITD 7 days later.

Participant Flow:   Overall Study
    ITD First, Sham Device Next     Sham Device First, ITD Next  
STARTED     2     0  
COMPLETED     2     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Sham Device A group of subjects will be randomized to receive the placebo sham device.
ITD Device A group of subjects will be randomized to receive Impedance Threshold Device.
Total Total of all reporting groups

Baseline Measures
    Sham Device     ITD Device     Total  
Number of Participants  
[units: participants]
 		  2     0     2  
Age  
[units: participants]
 		     
<=18 years     2         2  
Between 18 and 65 years     0         0  
>=65 years     0         0  
Gender  
[units: participants]
 		     
Female     NA [1]       0  
Male     NA [1]       0  
Region of Enrollment  
[units: participants]
 		     
United States     2         2  
[1] Data not analyzed- study closed due to lack of recruitment



  Outcome Measures
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1.  Primary:   Fluid Removal   [ Time Frame: 6 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Extra Days to Achieve Target Dry Weight   [ Time Frame: 6 weeks ]
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3.  Secondary:   Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.   [ Time Frame: 6 weeks ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Marsha Wallace
Organization: Children's Hospital of Philadelphia
phone: (215) 590-0119
e-mail: wallacem@email.chop.edu


No publications provided


Responsible Party: Vijay Srinivasan, 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