Urinary Tract Infection, Vesicoureteral Reflux
Conditions
Brief summary
The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.
Interventions
DRUGSulfur hexafluoride type-a lipid microspheres
Used as a contrast to enhance renal ultrasound
Sponsors
University of Tennessee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visualization of Renal Scars Compared to Previous Imaging | 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events Related to the Study Drug. | 1 week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Contrast All subjects will be recruited into this arm. All subjects will receive 0.03 ml/kg IV sulfur hexafluoride type-a lipid microspheres one time, unless a second, adjusted dose is necessary.
Sulfur hexafluoride type-a lipid microspheres: Used as a contrast to enhance renal ultrasound | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Contrast |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: 1 hour
Population: In addition to the 7 patients analyzed, 3 participants were excluded from this analysis because they did not have previous scars to analyze.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contrast | Visualization of Renal Scars Compared to Previous Imaging | 100 Percentage of previous scars visualized |
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.
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contrast | Number of Participants With Adverse Events Related to the Study Drug. | 1 participants |