NCT01323842

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
414

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

March 24, 2011

Last Update Submit

November 24, 2015

Conditions

Renal ColicHydronephrosisAbdominal Aortic Aneurysm

Keywords

renal colichydronephrosisabdominal aortic aneurysmultrasoundemergency medicineurolithiasis

Outcome Measures

Primary Outcomes (2)

  • 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.

    30 days

  • 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.

    1 hours

Secondary Outcomes (3)

  • ED length of stay

    1 day

  • radiation dose

    1 hour

  • accuracy in ruling out AAA

    1 hour

Study Arms (1)

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

EDTUPROCEDURE

bedside ultrasound imaging by the treating emergency physician

rule in renal colic

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

  • 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.

    PMID: 32507905DERIVED

MeSH Terms

Conditions

Renal ColicHydronephrosisAortic Aneurysm, AbdominalUrolithiasis

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Eric Bruder, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 28, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations

CA(1)