Study of Tomography of Nephrolithiasis Evaluation

NCT01451931 | Completed Phase 4 Results DMC

• 1 other identifier: RSB-1002670
• Study Type: interventional
• Target: 2,776
• Locations: 1 country
• Sites: 15

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.

Conditions

Urolithiasis

Keywords

kidney stone; urolithiasis; urinary tract infection; ultrasound; computed tomography; safety; cost; accuracy

Outcome Measures

Primary Outcomes (2)

• High Risk Diagnosis With Complication

  Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality.

  30 days from baseline

• Cumulative Radiation Exposure

  Baseline plus 6 months post-baseline

Secondary Outcomes (3)

• 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

Study Arms (3)

Point-of-care Ultrasound

EXPERIMENTAL

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

Other: Point-of-care Ultrasound

Radiology Ultrasound

EXPERIMENTAL

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

Radiation: Radiology Ultrasound

Radiology CT

EXPERIMENTAL

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

Other: Radiology CT

Interventions

Point-of-care Ultrasound OTHER

Perform ultrasonography in the ED (physician).

Point-of-care Ultrasound

Radiology Ultrasound RADIATION

Diagnostic ultrasound completed in the radiology department at time 0.

Radiology Ultrasound

Radiology CT OTHER

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

Radiology CT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (15)

UCSF at Fresno

Fresno, California, 93701, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63130, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Texas Houston Medical Center

Houston, Texas, 77026, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections

Results Point of Contact

• Title: Dr. Rebecca Smith-Bindman
• Organization: University of California, San Francisco

rebecca.smith-bindman@ucsf.edu

415-353-4946

Study Officials

• Rebecca Smith-Bindman, MD

  University of California, San Francisco, Department of Radiology and Biomedical Imaging

  PRINCIPAL INVESTIGATOR

• Clifford Rosen, MD

  Professor of Medicine, Tufts University (Data Safety Monitoring Board Chair)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 14, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 3, 2014
• Results First Posted: December 3, 2014

Record last verified: 2014-12

Locations

US (15)