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CompletedNCT01323842Updated Nov 26, 2015

Emergency Department Ultrasound in Renal Colic

An observational study in Renal Colic, Hydronephrosis and Abdominal Aortic Aneurysm, sponsored by Queen's University. Completed at 1 site in Canada. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-11-26.

Sponsored by Queen's University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
414
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Renal Colic
  • Hydronephrosis
  • Abdominal Aortic Aneurysm

Keywords

  • renal colic
  • hydronephrosis
  • abdominal aortic aneurysm
  • ultrasound
  • emergency medicine
  • urolithiasis
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In context

Renal Colic

79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.

This study's enrollment of 414 is close to the median of 452 across 16 observational studies indexed under Renal Colic.

Browse Renal Colic studies →

Lead sponsor

Queen's University is the lead sponsor of 207 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
414 participants (actual)

Groups and cohorts

  • 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

    Procedure: EDTU

Interventions

  • ProcedureEDTU

    bedside ultrasound imaging by the treating emergency physician

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

  2. 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.

    Time frame: 1 hours

Secondary outcomes

  1. 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)

    Time frame: 1 day

  2. radiation dose

    potential savings in radiation exposure from avoiding CT scanning

    Time frame: 1 hour

  3. 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.

    Time frame: 1 hour

07

Study locations

1 site
  • Kingston General Hospital
    Kingston, Ontario K7L 2V7, Canada
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References and documents

Publications

  • Sibley S, Roth N, Scott C, Rang L, White H, Sivilotti MLA, Bruder E. Point-of-care ultrasound for the detection of hydronephrosis in emergency department patients with suspected renal colic. Ultrasound J. 2020 Jun 8;12(1):31. doi: 10.1186/s13089-020-00178-3. PubMed 32507905 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01323842
Lead sponsor
Queen's University
Collaborators
Ontario Ministry of Health and Long Term Care
Responsible party
Dr. Marco L.A. Sivilotti (Research Director, Queen's University) — Principal investigator
First posted
Mar 28, 2011
Start date
Mar 2011
Primary completion
Jul 2013
Completion
Dec 2013
Last update
Nov 26, 2015

Study contacts

Eric Bruder, MD
principal investigator · Queen's University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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