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

Acute Renal Insufficiency Clinical Trial

— CANOPY  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02955979
• Other study ID #: 1608041
• Secondary ID: Y6D1846194a16-53
• Status: Terminated
• Start date: December 1, 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 . 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Insufficiency
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Lyon	Lyon
France	Chu Saint-Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine	data gathered in the medical file	change from baseline creatinine at 7 days
Primary	Diuresis	data gathered in the medical file	change from baseline diuresis at 7 days
Secondary	Readmission	Number of patients with no or having an adverse event during the readmission.	at 7 days
Secondary	Hospitalization in intensive care	Number of patients with no or having an adverse event during the hospitalization in intensive care.	at 7 days
Secondary	Renal replacement	Number of patients with no or having an adverse event during the renal replacement.	at 7 days
Secondary	Death	Number of dead	at 7 days