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Clinical Trials/NCT01323842
NCT01323842
Completed
Not Applicable

Hydro II: Emergency Department Ultrasound in Renal Colic

Queen's University1 site in 1 country414 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Colic
Sponsor
Queen's University
Enrollment
414
Locations
1
Primary Endpoint
diagnostic accuracy for hydronephrosis
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
December 2013
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Marco L.A. Sivilotti

Research Director

Queen's University

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 \< 90 or requiring vasopressors)
  • Fever (\>38 degrees C)
  • Leukocytes and nitrites on dipstick urinalysis (evidence of urinary tract infection)
  • Pregnancy
  • Renal transplant or single functioning kidney

Outcomes

Primary Outcomes

diagnostic accuracy for hydronephrosis

Time Frame: 1 hours

The accuracy of ED physicians in using EDTU to assess for hydronephrosis when compared to diagnostic imaging by CT or formal ultrasound.

complications post-ED visit in patients with and without negative EDTU.

Time Frame: 30 days

The frequency of complications by 30 days post-ED visit in patients with and without negative EDTU.

Secondary Outcomes

  • ED length of stay(1 day)
  • radiation dose(1 hour)
  • accuracy in ruling out AAA(1 hour)

Study Sites (1)

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