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

NCT02955979 | Terminated

• 3 other identifiers: 1608041Y6D1846194a16-532bis
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Renal Insufficiency

Keywords

acute renal insufficiency; Iodinated Contrast Agents; pediatric

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Readmission

  at 7 days

• Hospitalization in intensive care

  at 7 days

• Renal replacement

  at 7 days

• Death

  at 7 days

Study Arms (1)

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

Interventions

CT scan with iodinated contrast agents 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.

CT scan with iodinated contrast agents

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients under 16 years admitted to a participating service
• Patient receiving an injected CT scan

You may not qualify if:

• Opposition of parents.
• Chronic renal failure or end-stage requiring renal replacement in the long term.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (2)

CHU de Lyon

Lyon, 69310, France

Location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Olivier MORY, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 4, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)