Renal ColicNCT01323842
Emergency Department Ultrasound in Renal Colic
An observational study of Renal Colic and Hydronephrosis, run by Queen's University at 1 site in Canada.
Trial summary
Renal colic is a common (1300 visits per year at our institution) and painful condition caused by stones in the kidney and ureter, and can be mimicked by life threatening conditions such as a ruptured abdominal aortic aneurysm (AAA). This can create clinical uncertainty. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Renal Colic, Hydronephrosis, Abdominal Aortic Aneurysm
- What is being tested?
- EDTU
- Type of treatment
- Surgery or procedure
- How many people
- 414 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ED patients with suspected renal colic being imaged while in the ED
Who may be able to join
- Age 16 - 65 years
- Symptoms suggestive of renal colic
- EDTU performed within one hour (before or after) of formal imaging
- Imaging study arranged during this ED visit (includes next morning)
Who cannot join
- Hemodynamic instability (Pulse > 120 or SBP < 90 or requiring vasopressors)
- Fever (>38 degrees C)
- Leukocytes and nitrites on dipstick urinalysis (evidence of urinary tract infection)
- Pregnancy
- Inmate
- Renal transplant or single functioning kidney
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydro II: Emergency Department Ultrasound in Renal Colic
Renal colic is a common (1300 visits per year at our institution) and painful condition caused by stones in the kidney and ureter, and can be mimicked by life threatening conditions such as a ruptured abdominal aortic aneurysm (AAA). This can create clinical uncertainty. Emergency department targeted ultrasound (EDTU) is performed by an emergency physician at the patient's bedside, and has been shown to be accurate, safe, and efficient. We have shown that EDTU can accurately identify hydronephrosis, which is a predictor of complications of kidney stones. A normal formal ultrasound (US) predicts an uncomplicated clinical course. We will assess the accuracy of EDTU for the diagnosis of hydronephrosis, and when normal, whether patients can be safely discharged.
- Conditions
- Renal Colic, Hydronephrosis, Abdominal Aortic Aneurysm
- Being tested
- EDTU
- Keywords
- renal colic, hydronephrosis, abdominal aortic aneurysm, ultrasound, emergency medicine, urolithiasis
- Medical subject headings
- Renal Colic, Hydronephrosis, Aortic Aneurysm, Abdominal, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDTUProcedure or surgery
bedside ultrasound imaging by the treating emergency physician
| Study group | Role | What they receive |
|---|---|---|
| rule in renal colic | ED patients with abdominal/flank pain where a diagnosis of renal colic is being considered and undergoing formal imaging while in the ED Receives: Procedure: EDTU |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications post-ED visit in patients with and without negative EDTU.
The frequency of complications by 30 days post-ED visit in patients with and without negative EDTU.
Measured: 30 days
diagnostic accuracy for hydronephrosis
The accuracy of ED physicians in using EDTU to assess for hydronephrosis when compared to diagnostic imaging by CT or formal ultrasound.
Measured: 1 hours
Secondary outcomes (3)
ED length of stay
estimates of potential time of ED stay saved if a clinical decision is made on the basis of an EDTU (rather than waiting for formal diagnostic imaging)
Measured: 1 day
radiation dose
potential savings in radiation exposure from avoiding CT scanning
Measured: 1 hour
accuracy in ruling out AAA
accuracy of ED physicians in using EDTU to assess aortic size (and rule out AAA) when compared to diagnostic imaging by CT or formal ultrasound will also be validated.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Dr. Marco L.A. Sivilotti, Queen's University
- Investigators
- Eric Bruder, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323842
- Sponsor's protocol ID
- Hydro II
- Status last verified
- Nov 2015
- First submitted
- 24 Mar 2011
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sibley S, Roth N, Scott C, Rang L, White H, Sivilotti MLA, Bruder E. Point-of-care ultrasound for the detection of hydronephrosis in emergency department patients with suspected renal colic. Ultrasound J. 2020 Jun 8;12(1):31. doi: 10.1186/s13089-020-00178-3.
PubMed 32507905
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydro II: Emergency Department Ultrasound in Renal Colic
- ClinicalTrials.gov ID
- NCT01323842
- Acronym / sponsor ID
- Hydro II
- Conditions
- Renal Colic, Hydronephrosis, Abdominal Aortic Aneurysm
- Keywords
- renal colic, hydronephrosis, abdominal aortic aneurysm, ultrasound, emergency medicine, urolithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Mar 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Renal colic is a common (1300 visits per year at our institution) and painful condition caused by stones in the kidney and ureter, and can be mimicked by life threatening conditions such as a ruptured abdominal aortic aneurysm (AAA). This can create clinical uncertainty. Emergency department targeted ultrasound (EDTU) is performed by an emergency physician at the patient's bedside, and has been shown to be accurate, safe, and efficient. We have shown that EDTU can accurately identify hydronephrosis, which is a predictor of complications of kidney stones. A normal formal ultrasound (US) predicts an uncomplicated clinical course. We will assess the accuracy of EDTU for the diagnosis of hydronephrosis, and when normal, whether patients can be safely discharged.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rule in renal colic | – | Procedure: EDTUED patients with abdominal/flank pain where a diagnosis of renal colic is being considered and undergoing formal imaging while in the ED |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ED patients with suspected renal colic being imaged while in the ED
Key inclusion criteria (4 listed)
- Age 16 - 65 years
- Symptoms suggestive of renal colic
- EDTU performed within one hour (before or after) of formal imaging
- Imaging study arranged during this ED visit (includes next morning)
Key exclusion criteria (6 listed)
- Hemodynamic instability (Pulse > 120 or SBP < 90 or requiring vasopressors)
- Fever (>38 degrees C)
- Leukocytes and nitrites on dipstick urinalysis (evidence of urinary tract infection)
- Pregnancy
- Inmate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDTUbedside ultrasound imaging by the treating emergency physician | Procedure or surgery | rule in renal colic |
Primary outcome
complications post-ED visit in patients with and without negative EDTU.
Time frame: 30 days
The frequency of complications by 30 days post-ED visit in patients with and without negative EDTU.
diagnostic accuracy for hydronephrosis
Time frame: 1 hours
The accuracy of ED physicians in using EDTU to assess for hydronephrosis when compared to diagnostic imaging by CT or formal ultrasound.
3 secondary outcomes
ED length of stay
Time frame: 1 day
radiation dose
Time frame: 1 hour
accuracy in ruling out AAA
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
- Derived from this study: PubMed 32507905Sibley S, Roth N, Scott C, Rang L, White H, Sivilotti MLA, Bruder E. Point-of-care ultrasound for the detection of hydronephrosis in emergency department patients with suspected renal colic. Ultrasound J. 2020 Jun 8;12(1):31. doi: 10.1186/s13089-020-00178-3.
Related trials for Renal Colic
RecruitingPhase 3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
Renal Colic
Not yet recruiting
Relief Efficacy of Lidocaine Versus Morphine for Acute Renal Colic in the Emergency Department
Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia
Recruiting
Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief
Renal Colic, Acupuncture, Ear
Active, not recruiting
Sterile Water Injection vs Morphine for Renal Colic
Renal Colic, Urolithiasis
Not yet recruitingPhase 4
Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen in Renal Colic
Renal Colic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Bruder, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Colic and Hydronephrosis, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications post-ED visit in patients with and without negative EDTU. (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01323842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.