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

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ClinicalTrials.gov Identifier: NCT02955979
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date October 26, 2016
First Posted Date November 4, 2016
Last Update Posted Date February 21, 2019
Study Start Date December 8, 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 3, 2016)
  • Creatinine [ Time Frame: change from baseline creatinine at 7 days ]
    data gathered in the medical file
  • Diuresis [ Time Frame: change from baseline diuresis at 7 days ]
    data gathered in the medical file
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02955979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 3, 2016)
  • Readmission [ Time Frame: at 7 days ]
    Number of patients with no or having an adverse event during the readmission.
  • Hospitalization in intensive care [ Time Frame: at 7 days ]
    Number of patients with no or having an adverse event during the hospitalization in intensive care.
  • Renal replacement [ Time Frame: at 7 days ]
    Number of patients with no or having an adverse event during the renal replacement.
  • Death [ Time Frame: at 7 days ]
    Number of dead
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics
Official Title Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics. Study CANOPY. Prospective Multicenter Study
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients less than 16 years and who enjoys receiving an injected CT.
Condition Acute 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.

Study Groups/Cohorts 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).
Intervention: Other: CT scan with iodinated contrast agents
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 3, 2016)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Olivier MORY, MD (0)77828134 ext +33 olivier.mory@chu-st-etienne.fr
Contact: PEURIERE Marie, CRA (0)477829272 ext +33 marie.peuriere@chu-st-etienne.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02955979
Other Study ID Numbers 1608041
Y6D1846194a ( Registry Identifier: CNIL )
16-532bis ( Other Identifier: CCTIRS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators Not Provided
Investigators
Principal Investigator: Olivier MORY, MD CHU SAINT-ETIENNE
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date February 2019