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

NCT ID: NCT02955979

Last Updated: 2023-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2016-12-01

Brief Summary

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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

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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.

Conditions

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Acute Renal Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

CT scan with iodinated contrast agents

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier MORY, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU de Lyon

Lyon, , France

Site Status

Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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Y6D1846194a

Identifier Type: REGISTRY

Identifier Source: secondary_id

16-532bis

Identifier Type: OTHER

Identifier Source: secondary_id

1608041

Identifier Type: -

Identifier Source: org_study_id

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