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Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics

Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics. Study CANOPY. Prospective Multicenter Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02955979
Acronym
CANOPY
Enrollment
4
Registered
2016-11-04
Start date
2016-12-01
Completion date
2016-12-01
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Insufficiency

Keywords

acute renal insufficiency, Iodinated Contrast Agents, pediatric

Brief 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 . 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.

Interventions

OTHERCT 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion criteria

* Patients under 16 years admitted to a participating service * Patient receiving an injected CT scan

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Creatininechange from baseline creatinine at 7 daysdata gathered in the medical file
Diuresischange from baseline diuresis at 7 daysdata gathered in the medical file

Secondary

MeasureTime frameDescription
Readmissionat 7 daysNumber of patients with no or having an adverse event during the readmission.
Hospitalization in intensive careat 7 daysNumber of patients with no or having an adverse event during the hospitalization in intensive care.
Renal replacementat 7 daysNumber of patients with no or having an adverse event during the renal replacement.
Deathat 7 daysNumber of dead

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026