Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

Urinary Tract Infection Clinical Trial

Official title:

Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786810
• Other study ID #: 1504311FB
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: May 2016
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Urinary Tract Infection
• Urinary Tract Infections
• Vesico-Ureteral Reflux
• Vesicoureteral Reflux

Intervention

Drug:
• Sulfur hexafluoride type-a lipid microspheres
Used as a contrast to enhance renal ultrasound

Locations

Country	Name	City	State
United States	University of Tennessee Health Science Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

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