Renal ColicECHOLINENCT04169555
"Point of Care" Ultrasound and Renal Colic
A study testing Ultrasound in people with Renal Colic, run by Lille Catholic University at 1 site in France.
Trial summary
The management of renal colic in emergency departments follows the recommendations established at the 8th consensus conference of 2008 on the management of renal colic in emergency services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2019to Jul 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted in ER for suspicion of simple renal colic
- Signed informed consent
Who cannot join
- protected adults (tutorship or guardianship)
- fever ≥ 38.5°C
- chronic endstage kidney failure (Glomerular filtration rate < 30%)
- Solitary kidney
- Urinary tract catheter or percutaneous nephrectomy
- Pregnancy
- traumatic back pain
- Renal colic diagnosis in the past three months
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
GHICL
Lille, 59000
Hervé Duga, MD, 03 20 87 45 09 ext. 0033, duga.herve@ghicl.net
Hervé Duga, MD
About this study
Official title: Impact of the Use of "Point of Care" Ultrasound on the Length of Stay in the Emergency Department During an Episode of Renal Colic
The management of renal colic in emergency departments follows the recommendations established at the 8th consensus conference of 2008 on the management of renal colic in emergency services. It recommends the control of pain by nonsteroidal anti-inflammatory drugs and analgesics, the implementation of an urinary test strip and the use of emergency imaging for compiled forms and patient with medical specificities.
Currently, two imaging techniques are recommended during an episode of renal colic:
Read more
- Abdominal x-ray/Ultrasound or non-injected scanner for simple forms to be performed within 24-48h
- The non-injected scanner for complicated forms In simple forms, the decision to perform any examination remains at the discretion of the physician but with a tendency to carry out a scanner systematically even in the absence of criteria of severity or complication.
The use of the scanner exposes the patient to large doses of radiation even if it is a low dose scanner.
In recent years, studies have been conducted to determine whether the ultrasound, particularly "point of care" ultrasound performed by an emergency physician could be an alternative in the management of renal colic. Studies show that the sensitivity and specificity of ultrasound is comparable to that of the scanner. It has been found that the performance of an ultrasound by the emergency physician allows the decrease in irradiation and also in costs. In 2014,a study published in the New England Journal of Medicine emphasized that the ultrasound performed by the emergency physician would perform just as well as that performed by the radiologist and would result in a decreased time in the emergency room.
The Korean study, published in 2016 in the Clinical and Experimental Emergency Medicine (CEEM), despite some statistical inconsistencies, shows a significant reduction in the time of care by 74 minutes. In this context, we would like to conduct a single-centre, randomised, controlled, open-label study comparing a group of patients benefiting from point of care ultrasound versus a group of patients not benefiting from it. The goal is to determine whether the early ultrasound performed by the emergency physician by detecting expansions of the pelvicalyceal cavities reduces the time spent in the emergency department.
- Conditions
- Renal Colic
- Being tested
- Ultrasound, Standard care
- Keywords
- ultrasound, renal colic, emergency room, point of care
- Medical subject headings
- Renal Colic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
The emergency physician will perform a "point of care" ultrasound. If signs of expansions of the pelvicalyceal cavities are found, an early CT scan will follow
Standard careOther
Standard clinical care of patients. In regards of the clinical evolution and of biological results, a CT scan could be performed by the physician.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Not described Receives: Procedure: Ultrasound |
| Standard care | Other | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between admission and discharge from the emergency room
Measured: Day one
Secondary outcomes (3)
Patients satisfaction scale
5 questions to be answered by the patients rated on 1-10 scales being equivalent to 1 being equivalent to "no, certainly not and 10 being equivalent to "yes, certainly yes ". An overall score of 50 will be calculated to assess patient satisfaction.
Measured: An average of 24 hours
Physician satisfaction scale
5 questions to be answered by the physicians rated on 1-10 scales being equivalent to 1 being equivalent to "no, certainly not and 10 being equivalent to "yes, certainly yes ". An overall score of 50 will be calculated to assess physician satisfaction.
Measured: 9 months
Ultrasound diagnostic performance to detect expansions of the pelvicalyceal cavities
The diagnostic performance of the ultrasound for the detection of dilation of pyelocalicial cavities will be evaluated by sensitivity and specificity. The Gold Standard will be the result of the scanner
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start7 Oct 2019
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duga Hervé, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169555
- Sponsor's protocol ID
- RC-P0072
- Acronym
- ECHOLINE
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of "Point of Care" Ultrasound on the Length of Stay in the Emergency Department During an Episode of Renal Colic
- ClinicalTrials.gov ID
- NCT04169555
- Acronym / sponsor ID
- ECHOLINE / RC-P0072
- Conditions
- Renal Colic
- Keywords
- ultrasound, renal colic, emergency room, point of care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 20 Nov 2019 (actual)
- 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.
The management of renal colic in emergency departments follows the recommendations established at the 8th consensus conference of 2008 on the management of renal colic in emergency services. It recommends the control of pain by nonsteroidal anti-inflammatory drugs and analgesics, the implementation of an urinary test strip and the use of emergency imaging for compiled forms and patient with medical specificities.
Currently, two imaging techniques are recommended during an episode of renal colic:
- Abdominal x-ray/Ultrasound or non-injected scanner for simple forms to be performed within 24-48h
- The non-injected scanner for complicated forms In simple forms, the decision to perform any examination remains at the discretion of the physician but with a tendency to carry out a scanner systematically even in the absence of criteria of severity or complication.
The use of the scanner exposes the patient to large doses of radiation even if it is a low dose scanner.
In recent years, studies have been conducted to determine whether the ultrasound, particularly "point of care" ultrasound performed by an emergency physician could be an alternative in the management of renal colic. Studies show that the sensitivity and specificity of ultrasound is comparable to that of the scanner. It has been found that the performance of an ultrasound by the emergency physician allows the decrease in irradiation and also in costs. In 2014,a study published in the New England Journal of Medicine emphasized that the ultrasound performed by the emergency physician would perform just as well as that performed by the radiologist and would result in a decreased time in the emergency room.
The Korean study, published in 2016 in the Clinical and Experimental Emergency Medicine (CEEM), despite some statistical inconsistencies, shows a significant reduction in the time of care by 74 minutes. In this context, we would like to conduct a single-centre, randomised, controlled, open-label study comparing a group of patients benefiting from point of care ultrasound versus a group of patients not benefiting from it. The goal is to determine whether the early ultrasound performed by the emergency physician by detecting expansions of the pelvicalyceal cavities reduces the time spent in the emergency department.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Procedure: Ultrasound |
| Standard care | Other | Other: Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients admitted in ER for suspicion of simple renal colic
- Signed informed consent
Key exclusion criteria (8 listed)
- protected adults (tutorship or guardianship)
- fever ≥ 38.5°C
- chronic endstage kidney failure (Glomerular filtration rate < 30%)
- Solitary kidney
- Urinary tract catheter or percutaneous nephrectomy
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 |
|---|---|---|
| UltrasoundThe emergency physician will perform a "point of care" ultrasound. If signs of expansions of the pelvicalyceal cavities are found, an early CT scan will follow | Procedure or surgery | Ultrasound |
| Standard careStandard clinical care of patients. In regards of the clinical evolution and of biological results, a CT scan could be performed by the physician. | Other | Standard care |
Primary outcome
Time between admission and discharge from the emergency room
Time frame: Day one
3 secondary outcomes
Patients satisfaction scale
Time frame: An average of 24 hours
Physician satisfaction scale
Time frame: 9 months
Ultrasound diagnostic performance to detect expansions of the pelvicalyceal cavities
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Duga Hervé, MD principal investigator
GHICL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Renal Colic, run by Lille Catholic University at 1 site in France.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Nov 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie Lansiaux, MD, PhD (0320225269 ext. 0033, lansiaux.amelie@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between admission and discharge from the emergency room (time frame: Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2019.