Urinary Tract Infection Clinical Trial
Official title:
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
NCT number | NCT02786810 |
Other study ID # | 1504311FB |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | November 2016 |
Verified date | May 2016 |
Source | University of Tennessee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Informed consent - Age more than or equal to 8 years - Patient with history of urinary tract infection (UTI) and history of Voiding Cystourethrogram (VCUG) for vesicoureteral reflux - Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar - Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast Includes healthy volunteers Exclusion Criteria: - Age less than 8years - Allergy to contrast or related products - Cardiac shunt/ congenital heart anomalies - Abnormal baseline ECG - Open heart surgery - Evidence of retinopathy - Patient in intensive care - Unable to comply with study requirement - History of emphysema - Unable to maintain oxygen saturation of 92% on at room air - Pregnancy and lactation |
Country | Name | City | State |
---|---|---|---|
United States | University of Tennessee Health Science Center | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visualization of Renal Scars Compared to Previous Imaging | The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent. | 1 hour | |
Secondary | Number of Participants With Adverse Events Related to the Study Drug. | The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study. | 1 week |
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