Hydronephrosis on Ultrasound With CT Finding in Patients With Renal Colic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01349244
First received: May 4, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition
Hydronephrosis
Renal Colic

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Hydronephrosis on Point of Care Ultrasound With CT Finding in Patients With Expected Renal Colic

Further study details as provided by Yale University:

Primary Outcome Measures:
  • hydronephrosis bedside ultrasound [ Time Frame: Sept 2011-Jan 2013 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • hydronephrosis bedside ultrasound [ Time Frame: Sept 2011-Jan 2013 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • hydronephrosis [ Time Frame: Sept 2011-Jan 2013 ] [ Designated as safety issue: No ]
    To prospectively correlate the finding and degree of hydronephrosis on point of care ultrasound with stone size (a marker for likely spontaneous passage).


Enrollment: 97
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  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: NCT01349244

Locations
United States, Connecticut
Yale University, Emergency Department
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Christopher L Moore, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01349244     History of Changes
Other Study ID Numbers: IRB # 1006006943
Study First Received: May 4, 2011
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
hydronephrosis
CT
POC US

Additional relevant MeSH terms:
Hydronephrosis
Renal Colic
Colic
Kidney Diseases
Urologic Diseases
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on August 21, 2014