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Completed

NCT Number: NCT01323842

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.

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Key information

Conditions

Renal Colic Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hydronephrosis Kidney Diseases Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases Vascular Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EDTU

Procedure

bedside ultrasound imaging by the treating emergency physician

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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)

  2. radiation dose

    Time frame: 1 hour

    potential savings in radiation exposure from avoiding CT scanning

  3. 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.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Ontario Ministry of Health and Long Term Care

Registry information

Official study title

Hydro II: Emergency Department Ultrasound in Renal Colic

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2011
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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