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Clinical Trials/NCT02955979
NCT02955979
Terminated
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne2 sites in 1 country4 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Renal Insufficiency
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
4
Locations
2
Primary Endpoint
Diuresis
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
December 1, 2016
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Diuresis

Time Frame: change from baseline diuresis at 7 days

data gathered in the medical file

Creatinine

Time Frame: change from baseline creatinine at 7 days

data gathered in the medical file

Secondary Outcomes

  • Renal replacement(at 7 days)
  • Death(at 7 days)
  • Readmission(at 7 days)
  • Hospitalization in intensive care(at 7 days)

Study Sites (2)

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