Trial Outcomes & Findings for Study of Tomography of Nephrolithiasis Evaluation (NCT NCT01451931)
NCT ID: NCT01451931
Last Updated: 2014-12-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2776 participants
Primary outcome timeframe
30 days from baseline
Results posted on
2014-12-03
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
909
|
901
|
966
|
|
Overall Study
Baseline Data Collection
|
908
|
893
|
958
|
|
Overall Study
6-month Follow up
|
876
|
843
|
923
|
|
Overall Study
COMPLETED
|
876
|
843
|
923
|
|
Overall Study
NOT COMPLETED
|
33
|
58
|
43
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
36
|
21
|
|
Overall Study
Withdrawal by Subject
|
16
|
22
|
22
|
Baseline Characteristics
Study of Tomography of Nephrolithiasis Evaluation
Baseline characteristics by cohort
| Measure |
Point-of-care Ultrasound
n=908 Participants
Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician).
|
Radiology Ultrasound
n=893 Participants
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.
|
Computed Tomography
n=958 Participants
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.
|
Total
n=2759 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
888 Participants
n=5 Participants
|
866 Participants
n=7 Participants
|
918 Participants
n=5 Participants
|
2672 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
443 Participants
n=5 Participants
|
416 Participants
n=7 Participants
|
472 Participants
n=5 Participants
|
1331 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
465 Participants
n=5 Participants
|
477 Participants
n=7 Participants
|
486 Participants
n=5 Participants
|
1428 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
236 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
690 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
587 Participants
n=5 Participants
|
593 Participants
n=7 Participants
|
616 Participants
n=5 Participants
|
1796 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
218 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
668 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
685 Participants
n=5 Participants
|
663 Participants
n=7 Participants
|
727 Participants
n=5 Participants
|
2075 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
908 participants
n=5 Participants
|
893 participants
n=7 Participants
|
958 participants
n=5 Participants
|
2759 participants
n=4 Participants
|
|
History of Kidney Stones or Cancer
Prior Kidney Stones
|
377 number of participants
n=5 Participants
|
385 number of participants
n=7 Participants
|
387 number of participants
n=5 Participants
|
1149 number of participants
n=4 Participants
|
|
History of Kidney Stones or Cancer
No Kidney Stone
|
531 number of participants
n=5 Participants
|
508 number of participants
n=7 Participants
|
571 number of participants
n=5 Participants
|
1610 number of participants
n=4 Participants
|
|
Self-Reported Pain Score
|
8.3 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
8.1 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
8.1 units on a scale
STANDARD_DEVIATION 2.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: 30 days from baselineMissed 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.
Outcome measures
| Measure |
Point-of-care Ultrasound
n=908 Participants
Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician).
|
Radiology Ultrasound
n=893 Participants
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.
|
Computed Tomography
n=958 Participants
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.
|
|---|---|---|---|
|
High Risk Diagnosis With Complication
|
6 participants
|
3 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline plus 6 months post-baselineOutcome measures
| Measure |
Point-of-care Ultrasound
n=908 Participants
Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician).
|
Radiology Ultrasound
n=893 Participants
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.
|
Computed Tomography
n=958 Participants
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.
|
|---|---|---|---|
|
Cumulative Radiation Exposure
|
10.1 mSv
Standard Deviation 14.1
|
9.3 mSv
Standard Deviation 13.4
|
17.2 mSv
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline visit excluding hospitalizationOutcome measures
| Measure |
Point-of-care Ultrasound
n=908 Participants
Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician).
|
Radiology Ultrasound
n=893 Participants
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.
|
Computed Tomography
n=958 Participants
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.
|
|---|---|---|---|
|
ED Length of Stay
|
5.1 Hours
Interval 3.3 to 6.9
|
6.4 Hours
Interval 4.6 to 8.2
|
6.3 Hours
Interval 4.3 to 8.3
|
SECONDARY outcome
Timeframe: 6 months post-baselineOutcome measures
| Measure |
Point-of-care Ultrasound
n=908 Participants
Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician).
|
Radiology Ultrasound
n=893 Participants
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.
|
Computed Tomography
n=958 Participants
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.
|
|---|---|---|---|
|
Return Visits to ED or Hospital
Number of return visits to ED
|
231 Number of visits
|
231 Number of visits
|
255 Number of visits
|
|
Return Visits to ED or Hospital
Number of hospital readmissions
|
87 Number of visits
|
84 Number of visits
|
83 Number of visits
|
SECONDARY outcome
Timeframe: Up to 6 month follow-up for stone passageOutcome measures
| Measure |
Point-of-care Ultrasound
n=908 Participants
Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician).
|
Radiology Ultrasound
n=893 Participants
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.
|
Computed Tomography
n=958 Participants
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.
|
|---|---|---|---|
|
Accuracy for Stones by Arm
Sensitivity
|
85 Percent probability
Interval 80.0 to 89.0
|
84 Percent probability
Interval 79.0 to 89.0
|
86 Percent probability
Interval 82.0 to 90.0
|
|
Accuracy for Stones by Arm
Specificity
|
50 Percent probability
Interval 45.0 to 54.0
|
53 Percent probability
Interval 49.0 to 57.0
|
53 Percent probability
Interval 49.0 to 58.0
|
Adverse Events
Point-of-care Ultrasound
Serious events: 3 serious events
Other events: 110 other events
Deaths: 0 deaths
Radiology Ultrasound
Serious events: 4 serious events
Other events: 92 other events
Deaths: 0 deaths
Computed Tomography
Serious events: 5 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Point-of-care Ultrasound
n=908 participants at risk
Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician).
|
Radiology Ultrasound
n=893 participants at risk
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.
|
Computed Tomography
n=958 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Acute Cholecystitis
|
0.11%
1/908 • Number of events 1 • 6 months
|
0.11%
1/893 • Number of events 1 • 6 months
|
0.31%
3/958 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
Renal Insuff/ Pyelonephritis
|
0.11%
1/908 • Number of events 1 • 6 months
|
0.00%
0/893 • 6 months
|
0.00%
0/958 • 6 months
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.11%
1/908 • Number of events 1 • 6 months
|
0.00%
0/893 • 6 months
|
0.00%
0/958 • 6 months
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/908 • 6 months
|
0.11%
1/893 • Number of events 1 • 6 months
|
0.00%
0/958 • 6 months
|
|
Reproductive system and breast disorders
Ovarian Torsion
|
0.00%
0/908 • 6 months
|
0.11%
1/893 • Number of events 1 • 6 months
|
0.00%
0/958 • 6 months
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/908 • 6 months
|
0.11%
1/893 • Number of events 1 • 6 months
|
0.00%
0/958 • 6 months
|
|
Immune system disorders
Acute Allergy
|
0.00%
0/908 • 6 months
|
0.00%
0/893 • 6 months
|
0.10%
1/958 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/908 • 6 months
|
0.00%
0/893 • 6 months
|
0.10%
1/958 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Point-of-care Ultrasound
n=908 participants at risk
Patient with suspected urolithiasis received ultrasonography performed in the emergency department.
Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician).
|
Radiology Ultrasound
n=893 participants at risk
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.
|
Computed Tomography
n=958 participants at risk
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.
|
|---|---|---|---|
|
Renal and urinary disorders
Unrelated Urosepsis Pyelonephritis
|
0.55%
5/908 • Number of events 6 • 6 months
|
0.67%
6/893 • Number of events 8 • 6 months
|
0.42%
4/958 • Number of events 9 • 6 months
|
|
Renal and urinary disorders
Other - Various Unrelated
|
11.6%
105/908 • Number of events 168 • 6 months
|
9.6%
86/893 • Number of events 117 • 6 months
|
10.1%
97/958 • Number of events 146 • 6 months
|
Additional Information
Dr. Rebecca Smith-Bindman
University of California, San Francisco
Phone: 415-353-4946
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place