- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01323842
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
Conditions
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
-
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Kingston General Hospital
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-
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.
Sponsor
Collaborators
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hydro II
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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