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Completion not feasible. THERE ARE NO RESULTS FROM THIS TRIAL
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| Name | Class |
|---|---|
| Advanced Circulatory Systems | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Device first, ITD next | Experimental | Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days. |
|
| ITD first, sham device next | Experimental | Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITD | Device | ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluid Removal | Fluid removed as percentage of dry body weight. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Extra Days to Achieve Target Dry Weight | Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight | 6 weeks |
| Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vijay Srinivasan, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ITD First, Sham Device Next | A group of subjects will be randomized to receive the ITD first, followed by sham 7 days later. |
| FG001 | Sham Device First, ITD Next | A group of subjects will be randomized to receive sham first, followed by ITD 7 days later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Device | A group of subjects will be randomized to receive the placebo sham device. |
| BG001 | ITD Device | A group of subjects will be randomized to receive Impedance Threshold Device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fluid Removal | Fluid removed as percentage of dry body weight. | Data not analyzed - study closed due to lack of recruitment | Posted | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Device | A group of subjects will be randomized to receive the placebo sham device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marsha Wallace | Children's Hospital of Philadelphia | (215) 590-0119 | wallacem@email.chop.edu |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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|
| Sham | Device | Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions |
|
| 6 weeks |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Secondary | Extra Days to Achieve Target Dry Weight | Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight | Data not analyzed - study closed due to lack of recruitment | Posted | 6 weeks |
|
|
| Secondary | Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff. | Data not analyzed - study closed due to lack of recruitment | Posted | 6 weeks |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | ITD Device | A group of subjects will be randomized to receive Impedance Threshold Device. | 0 | 0 | 0 | 0 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |