Acute Renal InsufficiencyCANOPYNCT02955979
Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics
An observational study of Acute Renal Insufficiency, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Iodinated contrast media are now frequently used in diagnostic imaging exams, including pediatrics. In adults, the acute renal failure (ARF) associated with contrast agents (CA-AKI) occur in 3-33% of exposed patients, especially as the patient is fragile, has comorbidities or pre-existing renal aggression . Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Acute Renal Insufficiency
- What is being tested?
- CT scan with iodinated contrast agents
- Type of treatment
- Injection or infusion
- How many people
- 4 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2016to 1 Dec 2016
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: patients less than 16 years and who enjoys receiving an injected CT.
Who may be able to join
- Patients under 16 years admitted to a participating service
- Patient receiving an injected CT scan
Who cannot join
- Prior Inclusion in the study during an earlier review.
- Opposition of parents.
- Chronic renal failure or end-stage requiring renal replacement in the long term.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics. Study CANOPY. Prospective Multicenter Study
Iodinated contrast media are now frequently used in diagnostic imaging exams, including pediatrics.
In adults, the acute renal failure (ARF) associated with contrast agents (CA-AKI) occur in 3-33% of exposed patients, especially as the patient is fragile, has comorbidities or pre-existing renal aggression .
In children, the prevalence of this little known disease is probably underestimated.
The investigators intend to conduct a prospective epidemiological study, to estimate the impact of the acute renale failure to iodinated contrast agents in pediatrics.
Read the detailed description
Patients will be included those of pediatric emergencies, Hospitalization Unit of Short Duration pediatric, pediatric intensive care and pediatric resuscitation. The acute renale failure will be estimated on the basis of criteria KDIGO (score of kidney disease) group in 2012 to 48 hours a computed tomography (CT) scan with injection of contrast media, based on a change in creatinine clearance of the estimated according to the formula Schwartz revised in 2009 and / or diuresis.
Patient characteristics will be identified in order to establish risk factors.
- Conditions
- Acute Renal Insufficiency
- Being tested
- CT scan with iodinated contrast agents
- Keywords
- acute renal insufficiency, Iodinated Contrast Agents, pediatric
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan with iodinated contrast agentsOther
Before the CT scan, the investigators with iodinated contrast agents, the following data will be collected in the medical record: creatinine prior to injection, comorbidities and child characteristics, associated treatments and risk factors of acute renal failure, as well as the injection pattern.
After the CT scan the investigators will collect the characteristics of the injection type, osmolarity and volume of contrast used and the appearance of a possible allergic reaction.
Then 24 and 48 hours and day 7 will collect serum creatinine, urine output and vital replacement therapies may be necessary.
| Study group | Role | What they receive |
|---|---|---|
| CT scan with iodinated contrast agents | Patients under 16 years old and must pass a CT scan with iodinated contrast agents. The following data will be collected in the medical record (creatinine prior to injection, comorbidities and child characteristics, associated treatments and risk factors of acute renal failure, as well as the injection pattern). Receives: Other: CT scan with iodinated contrast agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine
data gathered in the medical file
Measured: change from baseline creatinine at 7 days
Diuresis
data gathered in the medical file
Measured: change from baseline diuresis at 7 days
Secondary outcomes (4)
Readmission
Number of patients with no or having an adverse event during the readmission.
Measured: at 7 days
Hospitalization in intensive care
Number of patients with no or having an adverse event during the hospitalization in intensive care.
Measured: at 7 days
Renal replacement
Number of patients with no or having an adverse event during the renal replacement.
Measured: at 7 days
Death
Number of dead
Measured: at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start1 Dec 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Why it stopped: Due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier MORY, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955979
- Sponsor's protocol ID
- 1608041
- Other IDs
- Y6D1846194a, 16-532bis
- Acronym
- CANOPY
- Status last verified
- Aug 2023
- First submitted
- 26 Oct 2016
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics. Study CANOPY. Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02955979
- Acronym / sponsor ID
- CANOPY / 1608041
- Conditions
- Acute Renal Insufficiency
- Keywords
- acute renal insufficiency, Iodinated Contrast Agents, pediatric
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to lack of funding
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 4 Nov 2016 (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.
Iodinated contrast media are now frequently used in diagnostic imaging exams, including pediatrics.
In adults, the acute renal failure (ARF) associated with contrast agents (CA-AKI) occur in 3-33% of exposed patients, especially as the patient is fragile, has comorbidities or pre-existing renal aggression .
In children, the prevalence of this little known disease is probably underestimated.
The investigators intend to conduct a prospective epidemiological study, to estimate the impact of the acute renale failure to iodinated contrast agents in pediatrics.
Detailed description
Patients will be included those of pediatric emergencies, Hospitalization Unit of Short Duration pediatric, pediatric intensive care and pediatric resuscitation. The acute renale failure will be estimated on the basis of criteria KDIGO (score of kidney disease) group in 2012 to 48 hours a computed tomography (CT) scan with injection of contrast media, based on a change in creatinine clearance of the estimated according to the formula Schwartz revised in 2009 and / or diuresis.
Patient characteristics will be identified in order to establish risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scan with iodinated contrast agents | – | Other: CT scan with iodinated contrast agentsPatients under 16 years old and must pass a CT scan with iodinated contrast agents. The following data will be collected in the medical record (creatinine prior to injection, comorbidities and child characteristics, associated treatments and risk factors of acute renal failure, as well as the injection pattern). |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients less than 16 years and who enjoys receiving an injected CT.
Key inclusion criteria (2 listed)
- Patients under 16 years admitted to a participating service
- Patient receiving an injected CT scan
Key exclusion criteria (3 listed)
- Prior Inclusion in the study during an earlier review.
- Opposition of parents.
- Chronic renal failure or end-stage requiring renal replacement in the long term.
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 |
|---|---|---|
| CT scan with iodinated contrast agentsBefore the CT scan, the investigators with iodinated contrast agents, the following data will be collected in the medical record: creatinine prior to injection, comorbidities and child characteristics, associated treatments and risk factors of acute renal failure, as well as the injection pattern. After the CT scan the investigators will collect the characteristics of the injection type, osmolarity and volume of contrast used and the appearance of a possible allergic reaction. Then 24 and 48 hours and day 7 will collect serum creatinine, urine output and vital replacement therapies may be necessary. | Other | CT scan with iodinated contrast agents |
Primary outcome
Creatinine
Time frame: change from baseline creatinine at 7 days
data gathered in the medical file
Diuresis
Time frame: change from baseline diuresis at 7 days
data gathered in the medical file
4 secondary outcomes
Readmission
Time frame: at 7 days
Hospitalization in intensive care
Time frame: at 7 days
Renal replacement
Time frame: at 7 days
Death
Time frame: at 7 days
Results and safety
The study was stopped early (reason given: Due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- 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.
Olivier MORY, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Insufficiency, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites 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 3 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: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Due to lack of funding). Results are not available in the source record.
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?
Creatinine (time frame: change from baseline creatinine at 7 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?
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 23 Aug 2023.