Emergency Department Ultrasound in Renal Colic

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Disease Information

Descriptive Information
Brief Title † Emergency Department Ultrasound in Renal Colic
Official Title † Hydro II: Emergency Department Ultrasound in Renal Colic
Brief Summary Renal colic is a common (1300 visits per year at our institution) and painful condition caused by stones in the kidney and ureter, and can be mimicked by life threatening conditions such as a ruptured abdominal aortic aneurysm (AAA). This can create clinical uncertainty. Emergency department targeted ultrasound (EDTU) is performed by an emergency physician at the patient's bedside, and has been shown to be accurate, safe, and efficient. We have shown that EDTU can accurately identify hydronephrosis, which is a predictor of complications of kidney stones. A normal formal ultrasound (US) predicts an uncomplicated clinical course. We will assess the accuracy of EDTU for the diagnosis of hydronephrosis, and when normal, whether patients can be safely discharged.
Detailed Description
Study Phase N/A
Study Type † Observational
Study Design † Observational Model: Cohort, Time Perspective: Prospective
Primary Outcome Measure † complications post-ED visit in patients with and without negative EDTU.
Secondary Outcome Measure † ED length of stay
Condition † Renal Colic Hydronephrosis Abdominal Aortic Aneurysm
Intervention † ProcedureEDTU
Study Arms / Comparison Groups rule in renal colic ED patients with abdominal/flank pain where a diagnosis of renal colic is being considered and undergoing formal imaging while in the ED
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 400
Start Date † March 2011
Completion Date December 2013
Primary Completion Date September 2013
Eligibility Criteria † Inclusion Criteria: - Age 16 - 65 years - Symptoms suggestive of renal colic - EDTU performed within one hour (before or after) of formal imaging - Imaging study arranged during this ED visit (includes next morning) Exclusion Criteria: - Hemodynamic instability (Pulse > 120 or SBP 38 degrees C) - Leukocytes and nitrites on dipstick urinalysis (evidence of urinary tract infection) - Pregnancy - Inmate - Renal transplant or single functioning kidney
Gender Both
Ages 16 Years - 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Canada
Administrative Information
NCT ID † NCT01323842
Organization ID Hydro II
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Queen's University
Collaborators †† Ontario Ministry of Health and Long Term Care
Investigators † Principal Investigator: Eric Bruder, MD, Queen's University
Information Provided By
Verification Date August 2013
First Received Date † March 24, 2011
Last Updated Date August 22, 2013
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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