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Emergency Department Ultrasound in Renal Colic

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01323842
First Posted: March 28, 2011
Last Update Posted: November 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Dr. Marco L.A. Sivilotti, Queen's University
  Purpose
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.

Condition Intervention
Renal Colic Hydronephrosis Abdominal Aortic Aneurysm Procedure: EDTU

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hydro II: Emergency Department Ultrasound in Renal Colic

Resource links provided by NLM:


Further study details as provided by Dr. Marco L.A. Sivilotti, Queen's University:

Primary Outcome Measures:
  • 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.

  • 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.


Secondary Outcome Measures:
  • 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)

  • radiation dose [ Time Frame: 1 hour ]
    potential savings in radiation exposure from avoiding CT scanning

  • 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.


Enrollment: 414
Study Start Date: March 2011
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
bedside ultrasound imaging by the treating emergency physician

  Eligibility

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ED patients with suspected renal colic being imaged while in the ED
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
  • Inmate
  • Renal transplant or single functioning kidney
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323842


Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Eric Bruder, MD Queen's University
  More Information

Responsible Party: Dr. Marco L.A. Sivilotti, Research Director, Queen's University
ClinicalTrials.gov Identifier: NCT01323842     History of Changes
Other Study ID Numbers: Hydro II
First Submitted: March 24, 2011
First Posted: March 28, 2011
Last Update Posted: November 26, 2015
Last Verified: November 2015

Keywords provided by Dr. Marco L.A. Sivilotti, Queen's University:
renal colic
hydronephrosis
abdominal aortic aneurysm
ultrasound
emergency medicine
urolithiasis

Additional relevant MeSH terms:
Emergencies
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Colic
Renal Colic
Hydronephrosis
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Kidney Diseases
Urologic Diseases