Emergency Department Ultrasound in Renal Colic

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Marco L.A. Sivilotti, Queen's University
ClinicalTrials.gov Identifier:
NCT01323842
First received: March 24, 2011
Last updated: August 22, 2013
Last verified: August 2013
  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 Queen's University:

Primary Outcome Measures:
  • complications post-ED visit in patients with and without negative EDTU. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    potential savings in radiation exposure from avoiding CT scanning

  • accuracy in ruling out AAA [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 400
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marco L.A. Sivilotti, Research Director, Queen's University
ClinicalTrials.gov Identifier: NCT01323842     History of Changes
Other Study ID Numbers: Hydro II
Study First Received: March 24, 2011
Last Updated: August 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by 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
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014