Randomized Controlled Trial of Ultrasound Versus CT (Computed Tomography) for Patients in the Emergency Department With Suspected Renal Colic

Study of Tomography of Nephrolithiasis Evaluation

Sponsors

Lead sponsor: University of California, San Francisco

Source University of California, San Francisco
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.

Overall Status Completed
Start Date September 2011
Completion Date September 2013
Primary Completion Date September 2013
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
High Risk Diagnosis With Complication 30 days from baseline
Cumulative Radiation Exposure Baseline plus 6 months post-baseline
Secondary Outcome
Measure Time Frame
ED Length of Stay Baseline visit excluding hospitalization
Return Visits to ED or Hospital 6 months post-baseline
Accuracy for Stones by Arm Up to 6 month follow-up for stone passage
Enrollment 2776
Condition
Intervention

Intervention type: Other

Intervention name: Point-of-care Ultrasound

Description: Perform ultrasonography in the ED (physician).

Arm group label: Point-of-care Ultrasound

Intervention type: Radiation

Intervention name: Radiology Ultrasound

Description: Diagnostic ultrasound completed in the radiology department at time 0.

Arm group label: Radiology Ultrasound

Intervention type: Other

Intervention name: Radiology CT

Description: Computed tomography of abdomen completed in the radiology department at time 0.

Arm group label: Radiology CT

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)

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Location
facility
UCSF at Fresno | Fresno, California, 93701, United States
University of California, Davis | Sacramento, California, 95817, United States
University of California, San Francisco | San Francisco, California, 94143, United States
Grady Memorial Hospital | Atlanta, Georgia, 30303, United States
John H. Stroger Jr. Hospital of Cook County | Chicago, Illinois, 60612, United States
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center | Boston, Massachusetts, 02215, United States
Hennepin County Medical Center | Minneapolis, Minnesota, 55415, United States
Washington University School of Medicine | St. Louis, Missouri, 63130, United States
Jacobi Medical Center | Bronx, New York, 10461, United States
Oregon Health and Science University | Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital | Providence, Rhode Island, 02903, United States
University of Texas Houston Medical Center | Houston, Texas, 77026, United States
University of Utah | Salt Lake City, Utah, 84132, United States
Location Countries

United States

Verification Date

December 2014

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Point-of-care Ultrasound

Arm group type: Experimental

Description: Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department. Perform ultrasonography in the ED (physician).

Arm group label: Radiology Ultrasound

Arm group type: Experimental

Description: Patient with suspected urolithiasis will receive diagnostic ultrasonography in the radiology department. Diagnostic ultrasound completed in the radiology department at time 0.

Arm group label: Radiology CT

Arm group type: Experimental

Description: Patient with suspected urolithiasis will receive computed tomography in the radiology department. Computed tomography of abdomen completed in the radiology department at time 0.

Acronym STONE
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov