Emergency Department Ultrasound in Renal Colic

November 24, 2015 updated by: Dr. Marco L.A. Sivilotti, Queen's University

Hydro II: Emergency Department Ultrasound in Renal Colic

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

414

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ED patients with suspected renal colic being imaged while in the ED

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
bedside ultrasound imaging by the treating emergency physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days
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.
1 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ED length of stay
Time Frame: 1 day
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
radiation dose
Time Frame: 1 hour
potential savings in radiation exposure from avoiding CT scanning
1 hour
accuracy in ruling out AAA
Time Frame: 1 hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric Bruder, MD, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (Estimate)

March 28, 2011

Study Record Updates

Last Update Posted (Estimate)

November 26, 2015

Last Update Submitted That Met QC Criteria

November 24, 2015

Last Verified

November 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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