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

Terminated

• Conditions: Acute Renal Insufficiency
• Interventions: Other: CT scan with iodinated contrast agents

• Registration Number: NCT02955979
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-04
• Study Start: 2016-12-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CT scan with iodinated contrast agents	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).

Primary Outcome Measures

Name	Time	Method
Diuresis	change from baseline diuresis at 7 days	data gathered in the medical file
Creatinine	change from baseline creatinine at 7 days	data gathered in the medical file

Secondary Outcome Measures

Name	Time	Method
Death	at 7 days	Number of dead
Renal replacement	at 7 days	Number of patients with no or having an adverse event during the renal replacement.
Readmission	at 7 days	Number of patients with no or having an adverse event during the readmission.
Hospitalization in intensive care	at 7 days	Number of patients with no or having an adverse event during the hospitalization in intensive care.

Trial Locations

Locations (2)

Chu Saint-Etienne; 🇫🇷 Saint Etienne, France

CHU de Lyon; 🇫🇷 Lyon, France