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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576524
Recruitment Status : Terminated (Completion not feasible. THERE ARE NO RESULTS FROM THIS TRIAL)
First Posted : December 19, 2007
Results First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Advanced Circulatory Systems
Information provided by (Responsible Party):
Vijay Srinivasan, Children's Hospital of Philadelphia

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Intradialytic Hypotension
End Stage Renal Disease
Low Blood Pressure
Interventions: Device: ITD
Device: Sham

  Participant Flow

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
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 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 2   0   2 
[Units: Participants]
<=18 years   2      2 
Between 18 and 65 years   0      0 
>=65 years   0      0 
Gender [1] 
[Units: Participants]
Female   NA [1]      0 
Male   NA [1]      0 
[1] Data not analyzed- study closed due to lack of recruitment
Region of Enrollment 
[Units: Participants]
United States   2      2 

  Outcome Measures

1.  Primary:   Fluid Removal   [ Time Frame: 6 weeks ]

2.  Secondary:   Extra Days to Achieve Target Dry Weight   [ Time Frame: 6 weeks ]

3.  Secondary:   Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.   [ Time Frame: 6 weeks ]

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Marsha Wallace
Organization: Children's Hospital of Philadelphia
phone: (215) 590-0119

Responsible Party: Vijay Srinivasan, Children's Hospital of Philadelphia Identifier: NCT00576524     History of Changes
Other Study ID Numbers: 2007-12-5712
First Submitted: December 17, 2007
First Posted: December 19, 2007
Results First Submitted: December 12, 2012
Results First Posted: February 26, 2013
Last Update Posted: February 26, 2013