Emergency Department Ultrasound in Renal Colic

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Hydro II: Emergency Department Ultrasound in Renal Colic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323842
• Other study ID #: Hydro II
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: November 24, 2015
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

• Inmate

• Renal transplant or single functioning kidney

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Colic
• Emergencies
• Hydronephrosis
• Renal Colic

Intervention

Procedure:
• EDTU
bedside ultrasound imaging by the treating emergency physician

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications post-ED visit in patients with and without negative EDTU.	The frequency of complications by 30 days post-ED visit in patients with and without negative EDTU.	30 days	Yes
Primary	diagnostic accuracy for hydronephrosis	The accuracy of ED physicians in using EDTU to assess for hydronephrosis when compared to diagnostic imaging by CT or formal ultrasound.	1 hours	No
Secondary	ED length of stay	estimates of potential time of ED stay saved if a clinical decision is made on the basis of an EDTU (rather than waiting for formal diagnostic imaging)	1 day	No
Secondary	radiation dose	potential savings in radiation exposure from avoiding CT scanning	1 hour	Yes
Secondary	accuracy in ruling out AAA	accuracy of ED physicians in using EDTU to assess aortic size (and rule out AAA) when compared to diagnostic imaging by CT or formal ultrasound will also be validated.	1 hour	Yes