Clinical trial NCT01451931: Study of Tomography of Nephrolithiasis Evaluation
Official title: Randomized Controlled Trial of Ultrasound Versus CT (Computed Tomography) for Patients in the Emergency Department With Suspected Renal Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urolithiasis
Keywords: kidney stone
urolithiasis
urinary tract infection
ultrasound
computed tomography
safety
cost
accuracy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 2776
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared to computed tomography (CT) for the initial emergency room evaluation of patients with suspected renal colic. The investigators will compare several measures of effectiveness including morbidity related to the patient's underlying disease, or complications related to delayed diagnosis, patient status regarding pain/missed days of work, and utilization of health care resources based on one of three study arms: ultrasound in the Emergency Department, ultrasound in Radiology or CT.

Detailed description: This is a multi-center, randomized controlled trial of ultrasonography compared with computed tomography (CT) for the evaluation of patients with suspected urolithiasis. The study will be conducted at 15 large urban Emergency Departments (EDs), reflecting geographic, socioeconomic, racial and ethnic diversity, and include academic medical centers as well as safety net hospitals. The patients will be randomized to one of three arms: 1) ultrasound in the Emergency Department (ED), 2) ultrasound in radiology or 3) CT in radiology. The investigators will then collect precise and unbiased data on a comprehensive range of outcomes that will allow assessment of effectiveness, safety, accuracy and cost between patients randomized to one the three groups. Taken together, these measures are intended to provide the basis for a valid comparison of imaging of patients with suspected urolithiasis seen in the ED. The results of this trial could lead to a change in clinical practice that is associated with both improved patient outcomes and reduced cost. Broad stakeholder involvement from within radiology, emergency medicine and several subspecialty communities has been sought to ensure the strategic completion of study aims and to help rapidly disseminate the results of the study into clinical practice. This will create a collaborative network of EDs willing to act as a laboratory for studying the comparative effectiveness of diagnostic testing. As a result, the proposed trial will demonstrate the feasibility of conducting Randomized Control Trials (RCTs) of imaging that incorporates measurements of outcomes that can be expanded to additional imaging tests in the future.

Eligibility criteria: Inclusion Criteria:

* men or women = or \>18 but \<76 years of age presenting with acute renal colic
* Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones.

Exclusion Criteria:

* children \< 18 years old
* elderly patients \> or = 76 years old
* pregnancy or planning pregnancy
* Morbid obesity (\>285 pounds in men, \>250 pounds in women)
* patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected).
* history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)

Primary outcomes:
measure: High Risk Diagnosis With Complication
timeFrame: 30 days from baseline
measure: Cumulative Radiation Exposure
timeFrame: Baseline plus 6 months post-baseline
Secondary outcomes:
measure: ED Length of Stay
timeFrame: Baseline visit excluding hospitalization
measure: Return Visits to ED or Hospital
timeFrame: 6 months post-baseline
measure: Accuracy for Stones by Arm
timeFrame: Up to 6 month follow-up for stone passage
Other outcomes:
Locations:
city: Fresno
country: United States
facility: UCSF at Fresno
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital of Cook County
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: University of Texas Houston Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of California, San Francisco, Department of Radiology and Biomedical Imaging
name: Rebecca Smith-Bindman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Medicine, Tufts University (Data Safety Monitoring Board Chair)
name: Clifford Rosen, MD
role: STUDY_CHAIR
References: