Urolithiasis
Conditions
Keywords
kidney stone, urolithiasis, urinary tract infection, ultrasound, computed tomography, safety, cost, accuracy
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.
Interventions
OTHERPoint-of-care Ultrasound
Perform ultrasonography in the ED (physician).
RADIATIONRadiology Ultrasound
Diagnostic ultrasound completed in the radiology department at time 0.
OTHERRadiology CT
Computed tomography of abdomen completed in the radiology department at time 0.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Risk Diagnosis With Complication | 30 days from baseline | 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. |
| Cumulative Radiation Exposure | Baseline plus 6 months post-baseline | — |
Secondary
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Point-of-care Ultrasound Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician). | 908 |
| Radiology Ultrasound Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.
Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0. | 893 |
| Computed Tomography Patient with suspected urolithiasis received computed tomography in the radiology department.
CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0. | 958 |
| Total | 2,759 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 36 | 21 |
| Overall Study | Withdrawal by Subject | 16 | 22 | 22 |
Baseline characteristics
| Characteristic | Total | Point-of-care Ultrasound | Radiology Ultrasound | Computed Tomography |
|---|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 4 Participants | 5 Participants | 12 Participants |
| Age, Categorical >=65 years | 66 Participants | 16 Participants | 22 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 2672 Participants | 888 Participants | 866 Participants | 918 Participants |
| Age, Continuous | 40.4 years STANDARD_DEVIATION 12.7 | 40.1 years STANDARD_DEVIATION 12.4 | 40.4 years STANDARD_DEVIATION 12.8 | 40.7 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 668 Participants | 218 Participants | 224 Participants | 226 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2075 Participants | 685 Participants | 663 Participants | 727 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 5 Participants | 6 Participants | 5 Participants |
| History of Kidney Stones or Cancer No Kidney Stone | 1610 number of participants | 531 number of participants | 508 number of participants | 571 number of participants |
| History of Kidney Stones or Cancer Prior Kidney Stones | 1149 number of participants | 377 number of participants | 385 number of participants | 387 number of participants |
| Race (NIH/OMB) American Indian or Alaska Native | 38 Participants | 12 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) Asian | 125 Participants | 35 Participants | 39 Participants | 51 Participants |
| Race (NIH/OMB) Black or African American | 690 Participants | 236 Participants | 213 Participants | 241 Participants |
| Race (NIH/OMB) More than one race | 88 Participants | 32 Participants | 33 Participants | 23 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 5 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) White | 1796 Participants | 587 Participants | 593 Participants | 616 Participants |
| Region of Enrollment United States | 2759 participants | 908 participants | 893 participants | 958 participants |
| Self-Reported Pain Score | 8.1 units on a scale STANDARD_DEVIATION 2.2 | 8.3 units on a scale STANDARD_DEVIATION 2 | 8.0 units on a scale STANDARD_DEVIATION 2.4 | 8.1 units on a scale STANDARD_DEVIATION 2.2 |
| Sex: Female, Male Female | 1331 Participants | 443 Participants | 416 Participants | 472 Participants |
| Sex: Female, Male Male | 1428 Participants | 465 Participants | 477 Participants | 486 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 110 / 908 | 92 / 893 | 101 / 958 |
| serious Total, serious adverse events | 3 / 908 | 4 / 893 | 5 / 958 |
Outcome results
Primary
Cumulative Radiation Exposure
Time frame: Baseline plus 6 months post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Point-of-care Ultrasound | Cumulative Radiation Exposure | 10.1 mSv | Standard Deviation 14.1 |
| Radiology Ultrasound | Cumulative Radiation Exposure | 9.3 mSv | Standard Deviation 13.4 |
| Computed Tomography | Cumulative Radiation Exposure | 17.2 mSv | Standard Deviation 13.4 |
Primary
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.
Time frame: 30 days from baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Point-of-care Ultrasound | High Risk Diagnosis With Complication | 6 participants |
| Radiology Ultrasound | High Risk Diagnosis With Complication | 3 participants |
| Computed Tomography | High Risk Diagnosis With Complication | 2 participants |
Secondary
Accuracy for Stones by Arm
Time frame: Up to 6 month follow-up for stone passage
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Point-of-care Ultrasound | Accuracy for Stones by Arm | Sensitivity | 85 Percent probability |
| Point-of-care Ultrasound | Accuracy for Stones by Arm | Specificity | 50 Percent probability |
| Radiology Ultrasound | Accuracy for Stones by Arm | Sensitivity | 84 Percent probability |
| Radiology Ultrasound | Accuracy for Stones by Arm | Specificity | 53 Percent probability |
| Computed Tomography | Accuracy for Stones by Arm | Sensitivity | 86 Percent probability |
| Computed Tomography | Accuracy for Stones by Arm | Specificity | 53 Percent probability |
Secondary
ED Length of Stay
Time frame: Baseline visit excluding hospitalization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Point-of-care Ultrasound | ED Length of Stay | 5.1 Hours |
| Radiology Ultrasound | ED Length of Stay | 6.4 Hours |
| Computed Tomography | ED Length of Stay | 6.3 Hours |
Secondary
Return Visits to ED or Hospital
Time frame: 6 months post-baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Point-of-care Ultrasound | Return Visits to ED or Hospital | Number of return visits to ED | 231 Number of visits |
| Point-of-care Ultrasound | Return Visits to ED or Hospital | Number of hospital readmissions | 87 Number of visits |
| Radiology Ultrasound | Return Visits to ED or Hospital | Number of return visits to ED | 231 Number of visits |
| Radiology Ultrasound | Return Visits to ED or Hospital | Number of hospital readmissions | 84 Number of visits |
| Computed Tomography | Return Visits to ED or Hospital | Number of return visits to ED | 255 Number of visits |
| Computed Tomography | Return Visits to ED or Hospital | Number of hospital readmissions | 83 Number of visits |