Trial Outcomes & Findings for Feasibility and Impact of a Decision Rule for Imaging of Emergency Department Patients With Suspected Kidney Stone (NCT NCT01869647)
NCT ID: NCT01869647
Last Updated: 2020-03-20
Results Overview
Radiation exposure at baseline was collected using the mean dose length product mGy\*cm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
264 participants
Primary outcome timeframe
Baseline (at enrollment)
Results posted on
2020-03-20
Participant Flow
Participant milestones
| Measure |
"High" Likelihood of Stone Group
Subjects in the "high" likelihood of stone group will be eligible to get either ULDCT or "expectant management". The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.
"high" likelihood of stone group: Ultra low dose CT scan
|
"Moderate" Likelihood of Stone Group
Subjects in the "moderate" likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.
"moderate" likelihood of stone group: Regular CT or Low Dose CT scan
|
"Low" Likelihood of Stone Group
In the "low" likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.
"low" likelihood of stone group: No imaging
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
136
|
62
|
|
Overall Study
COMPLETED
|
65
|
130
|
62
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility and Impact of a Decision Rule for Imaging of Emergency Department Patients With Suspected Kidney Stone
Baseline characteristics by cohort
| Measure |
"High" Likelihood of Stone Group
n=66 Participants
Subjects in the "high" likelihood of stone group will be eligible to get either ULDCT or "expectant management". The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.
"high" likelihood of stone group: Ultra low dose CT scan
|
"Moderate" Likelihood of Stone Group
n=136 Participants
Subjects in the "moderate" likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.
"moderate" likelihood of stone group: Regular CT or Low Dose CT scan
|
"Low" Likelihood of Stone Group
n=62 Participants
In the "low" likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.
"low" likelihood of stone group: No imaging
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
245 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
44.0 years
STANDARD_DEVIATION 13.7 • n=107 Participants
|
46.1 years
STANDARD_DEVIATION 14.7 • n=206 Participants
|
44.0 years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
118 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
146 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=99 Participants
|
136 participants
n=107 Participants
|
62 participants
n=206 Participants
|
264 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline (at enrollment)Radiation exposure at baseline was collected using the mean dose length product mGy\*cm.
Outcome measures
| Measure |
"High" Likelihood of Stone Group
n=65 Participants
Subjects in the "high" likelihood of stone group will be eligible to get either ULDCT or "expectant management". The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.
"high" likelihood of stone group: Ultra low dose CT scan
|
"Moderate" Likelihood of Stone Group
n=130 Participants
Subjects in the "moderate" likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.
"moderate" likelihood of stone group: Regular CT or Low Dose CT scan
|
"Low" Likelihood of Stone Group
n=62 Participants
In the "low" likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.
"low" likelihood of stone group: No imaging
|
|---|---|---|---|
|
Radiation Exposure (Dose-Length-Product) at Baseline
|
293.5 mGy*cm
Interval 210.5 to 377.0
|
482.1 mGy*cm
Interval 398.2 to 566.0
|
915.99 mGy*cm
Interval 834.2 to 998.0
|
SECONDARY outcome
Timeframe: 90 daysThis measure presents the prevalence of participants needing urological intervention in each arm within 90 days.
Outcome measures
| Measure |
"High" Likelihood of Stone Group
n=65 Participants
Subjects in the "high" likelihood of stone group will be eligible to get either ULDCT or "expectant management". The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.
"high" likelihood of stone group: Ultra low dose CT scan
|
"Moderate" Likelihood of Stone Group
n=130 Participants
Subjects in the "moderate" likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.
"moderate" likelihood of stone group: Regular CT or Low Dose CT scan
|
"Low" Likelihood of Stone Group
n=62 Participants
In the "low" likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.
"low" likelihood of stone group: No imaging
|
|---|---|---|---|
|
Prevalence of Urological Intervention
|
19 participants
|
24 participants
|
3 participants
|
Adverse Events
"High" Likelihood of Stone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
"Moderate" Likelihood of Stone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
"Low" Likelihood of Stone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place