Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics (CANOPY)
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|ClinicalTrials.gov Identifier: NCT02955979|
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : February 16, 2018
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.
|Condition or disease||Intervention/treatment|
|Acute Renal Insufficiency||Other: CT scan with iodinated contrast agents|
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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics. Study CANOPY. Prospective Multicenter Study|
|Study Start Date :||December 8, 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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).
Other: CT scan with iodinated contrast agents
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.
- 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
- Readmission [ Time Frame: at 7 days ]Number of patients with no or having an adverse event during the readmission.
- Hospitalization in intensive care [ Time Frame: at 7 days ]Number of patients with no or having an adverse event during the hospitalization in intensive care.
- Renal replacement [ Time Frame: at 7 days ]Number of patients with no or having an adverse event during the renal replacement.
- Death [ Time Frame: at 7 days ]Number of dead
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955979
|Contact: Olivier MORY, MD||(0)77828134 ext +email@example.com|
|Contact: PEURIERE Marie, CRA||(0)477829272 ext +firstname.lastname@example.org|
|CHU de Lyon||Recruiting|
|Lyon, France, 69310|
|Contact: Etienne Javouhey, MD PhD (0)472129735 ext +33 email@example.com|
|Principal Investigator: Etienne Javouhey, MD PhD|
|Sub-Investigator: Yves Gillet, MD PhD|
|Saint Etienne, France, 42055|
|Contact: Olivier MORY, MD (0)477828632 ext +33 firstname.lastname@example.org|
|Principal Investigator: Olivier MORY, MD|
|Sub-Investigator: Aymeric CANTAIS, MD|
|Sub-Investigator: Hugues PATURAL, MD PhD|
|Principal Investigator:||Olivier MORY, MD||CHU SAINT-ETIENNE|