Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis (ITD)
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intradialytic Hypotension End Stage Renal Disease Low Blood Pressure | Device: ITD Device: Sham | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (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 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | February 2011 |
Actual Study Completion Date : | February 2011 |

Arm | Intervention/treatment |
---|---|
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
|
- Fluid Removal [ Time Frame: 6 weeks ]Fluid removed as percentage of dry body weight.
- 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 ]

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Ages Eligible for Study: | 8 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576524
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Vijay Srinivasan, MD | Children's Hospital of Philadelphia |
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 |
First Posted: | December 19, 2007 Key Record Dates |
Results First Posted: | February 26, 2013 |
Last Update Posted: | February 26, 2013 |
Last Verified: | January 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 Hypotension Urologic Diseases |
Renal Insufficiency, Chronic Renal Insufficiency Vascular Diseases Cardiovascular Diseases |