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

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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Renal Insufficiency
• Intervention / Treatment: Other: CT scan with iodinated contrast agents

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 Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

• Study Contact: Name: Olivier MORY, MD; Phone Number: +33 (0)77828134; Email: olivier.mory@chu-st-etienne.fr
• Study Contact Backup: Name: PEURIERE Marie, CRA; Phone Number: +33 (0)477829272; Email: marie.peuriere@chu-st-etienne.fr

Study Locations

• France
  • Lyon, France, 69310
    • Chu de Lyon
  • Saint Etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients less than 16 years and who enjoys receiving an injected CT.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatinine	data gathered in the medical file	change from baseline creatinine at 7 days
Diuresis	data gathered in the medical file	change from baseline diuresis at 7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Olivier MORY, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimated): November 4, 2016

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pediatric; acute renal insufficiency; Iodinated Contrast Agents
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 1608041; Y6D1846194a (Registry Identifier: CNIL); 16-532bis (Other Identifier: CCTIRS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No