Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis (ITD)
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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 |
- Fluid Removal [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Fluid removed as percentage of dry body weight.
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
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 Failure, Chronic Cardiovascular Diseases Kidney Diseases |
Renal Insufficiency Renal Insufficiency, Chronic Urologic Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on February 27, 2015