Hydronephrosis on Ultrasound With CT Finding in Patients With Renal Colic

Renal Colic Clinical Trial

Official title:

Correlation of Hydronephrosis on Point of Care Ultrasound With CT Finding in Patients With Expected Renal Colic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349244
• Other study ID #: IRB # 1006006943
• Status: Completed
• Phase: N/A
• First received: May 4, 2011
• Last updated: July 8, 2014
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: July 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the overall sensitivity and specificity of hydronephrosis on point-of-care bedside ultrasound to identify hydronephrosis as compared to hydronephrosis found by CT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Emergency Department patients 18 yrs or older with suspected renal colic in whom the clinician intends to obtain a CT scan to diagnose kidney stone.

• Informed consent will be required prior to enrollment in the study.

Exclusion Criteria:

• Known renal disease (any ESRD, transplant, PCKD), dementia, trauma, language barrier, incarcerated patients, and patients who do not undergo CT.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colic
• Hydronephrosis
• Renal Colic

Locations

Country	Name	City	State
United States	Yale University, Emergency Department	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hydronephrosis	To prospectively correlate the finding and degree of hydronephrosis on point of care ultrasound with stone size (a marker for likely spontaneous passage).	Sept 2011-Jan 2013	No
Primary	hydronephrosis bedside ultrasound	To determine the overall sensitivity and specificity of hydronephrosis on point-of-care bedside ultrasound to identify hydronephrosis as compared to hydronephrosis found on by CT.	Sept 2011-Jan 2013	No
Secondary	hydronephrosis bedside ultrasound	To determine test performance characteristics of hydronephrosis on point of care ultrasound with the goal of incorporating POC US into a prospective rule for determining which patients with suspected renal colic require CT evaluation.	Sept 2011-Jan 2013	No