End Stage Renal Disease, Intradialytic Hypotension, Low Blood Pressure
Conditions
Keywords
Hypotension during dialysis, End Stage Renal Disease, Decrease complications during dialysis, Low Blood Pressure
Brief 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.
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.
Interventions
DEVICEITD
ITD will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
DEVICESham
Sham will be applied for 30 minutes at a time with 10 minute breaks for the entire duration of hemodialysis on 2 separate occasions
Sponsors
Advanced Circulatory Systems
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluid Removal | 6 weeks | Fluid removed as percentage of dry body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extra Days to Achieve Target Dry Weight | 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. | 6 weeks | — |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| Sham Device A group of subjects will be randomized to receive the placebo sham device. | 2 |
| ITD Device A group of subjects will be randomized to receive Impedance Threshold Device. | 0 |
| Total | 2 |
Baseline characteristics
| Characteristic | Sham Device | Total |
|---|---|---|
| Age Categorical <=18 years | 2 participants | 2 participants |
| Age Categorical >=65 years | 0 participants | 0 participants |
| Age Categorical Between 18 and 65 years | 0 participants | 0 participants |
| Region of Enrollment United States | 2 participants | 2 participants |
| Sex: Female, Male Female | NA Participants | 0 Participants |
| Sex: Female, Male Male | NA Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
Fluid Removal
Fluid removed as percentage of dry body weight.
Time frame: 6 weeks
Population: Data not analyzed - study closed due to lack of recruitment
Secondary
Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.
Time frame: 6 weeks
Population: Data not analyzed - study closed due to lack of recruitment
Secondary
Extra Days to Achieve Target Dry Weight
Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight
Time frame: 6 weeks
Population: Data not analyzed - study closed due to lack of recruitment