Hydronephrosis on Ultrasound With CT Finding in Patients With Renal Colic

July 8, 2014 updated by: Yale University

Correlation of Hydronephrosis on Point of Care Ultrasound With CT Finding in Patients With Expected Renal Colic

The purpose of this study is to determine the overall sensitivity and specificity of hydronephrosis on point-of-care bedside ultrasound to identify hydronephrosis as compared to hydronephrosis found by CT.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University, Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This will be a prospective observational study involving a convenience sample of all ED patients scheduled for NCT at some point during their emergency department visit.

Description

Inclusion Criteria:

  • Emergency Department patients 18 yrs or older with suspected renal colic in whom the clinician intends to obtain a CT scan to diagnose kidney stone.
  • Informed consent will be required prior to enrollment in the study.

Exclusion Criteria:

  • Known renal disease (any ESRD, transplant, PCKD), dementia, trauma, language barrier, incarcerated patients, and patients who do not undergo CT.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hydronephrosis bedside ultrasound
Time Frame: Sept 2011-Jan 2013
To determine the overall sensitivity and specificity of hydronephrosis on point-of-care bedside ultrasound to identify hydronephrosis as compared to hydronephrosis found on by CT.
Sept 2011-Jan 2013

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hydronephrosis bedside ultrasound
Time Frame: Sept 2011-Jan 2013
To determine test performance characteristics of hydronephrosis on point of care ultrasound with the goal of incorporating POC US into a prospective rule for determining which patients with suspected renal colic require CT evaluation.
Sept 2011-Jan 2013

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
hydronephrosis
Time Frame: Sept 2011-Jan 2013
To prospectively correlate the finding and degree of hydronephrosis on point of care ultrasound with stone size (a marker for likely spontaneous passage).
Sept 2011-Jan 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Christopher L Moore, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (Estimate)

May 6, 2011

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB # 1006006943

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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