Intradialytic HypotensionPhase 2ITDNCT00576524
Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis
A Phase 2 study testing ITD in people with Intradialytic Hypotension and End Stage Renal Disease, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Intradialytic Hypotension, End Stage Renal Disease, Low Blood Pressure
- What is being tested?
- ITD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects 8-18 years of age
- Subjects undergoing hemodialysis for ESRD
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Application of Impedance Threshold Device Technologies to Treat and Prevent Intradialytic Hypotension in Children Undergoing Hemodialysis
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.
Read the 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.
- Being tested
- ITD, Sham
- Keywords
- Hypotension during dialysis, End Stage Renal Disease, Decrease complications during dialysis, Low Blood Pressure
- Medical subject headings
- Kidney Failure, Chronic, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITDDevice
Also called ResQpod
ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
ShamDevice
Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
| Study group | Role | What they receive |
|---|---|---|
| Sham Device first, ITD next | Experimental | Subjects will be randomized to recieve sham device first, ITD next after washout of 7 days. Receives: Device: ITD; Device: Sham |
| ITD first, sham device next | Experimental | Subjects will be randomized to receive ITD first, sham device next, after washout of 7 days. Receives: Device: ITD; Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Removal
Fluid removed as percentage of dry body weight.
Measured: 6 weeks
Secondary outcomes (2)
Extra Days to Achieve Target Dry Weight
Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight
Measured: 6 weeks
Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startSep 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Completion not feasible. THERE ARE NO RESULTS FROM THIS TRIAL
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Circulatory Systems
- Responsible party
- Principal investigator, Vijay Srinivasan, Children's Hospital of Philadelphia
- Investigators
- Vijay Srinivasan, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576524
- Sponsor's protocol ID
- 2007-12-5712
- Acronym
- ITD
- Status last verified
- Jan 2013
- First submitted
- 17 Dec 2007
- Last updated
- 26 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Impedance Threshold Device Technologies to Treat and Prevent Intradialytic Hypotension in Children Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT00576524
- Acronym / sponsor ID
- ITD / 2007-12-5712
- Keywords
- Hypotension during dialysis, End Stage Renal Disease, Decrease complications during dialysis, Low Blood Pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Completion not feasible. THERE ARE NO RESULTS FROM THIS TRIAL
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Advanced Circulatory Systems
- Study start
- Sep 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Posted 26 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Device first, ITD next | Experimental | Device: ITD, Device: ShamSubjects will be randomized to recieve sham device first, ITD next after washout of 7 days. |
| ITD first, sham device next | Experimental | Device: ITD, Device: ShamSubjects will be randomized to receive ITD first, sham device next, after washout of 7 days. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Subjects 8-18 years of age
- Subjects undergoing hemodialysis for ESRD
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITDAlso: ResQpodITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions | Device | ITD first, sham device next, Sham Device first, ITD next |
| ShamSham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions | Device | ITD first, sham device next, Sham Device first, ITD next |
Primary outcome
Fluid Removal
Time frame: 6 weeks
Fluid removed as percentage of dry body weight.
2 secondary outcomes
Extra Days to Achieve Target Dry Weight
Time frame: 6 weeks
Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Intradialytic Hypotension
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay Srinivasan, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ITD in people with Intradialytic Hypotension and End Stage Renal Disease, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid Removal (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2013.