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Trial record 2 of 9 for:    CANOPY

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT02955979
First received: October 26, 2016
Last updated: December 12, 2016
Last verified: October 2016
  Purpose

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.


Condition Intervention
Acute Renal Insufficiency
Other: CT scan with iodinated contrast agents

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics. Study CANOPY. Prospective Multicenter Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Creatinine [ Time Frame: change from baseline creatinine at 7 days ] [ Designated as safety issue: No ]
    data gathered in the medical file

  • Diuresis [ Time Frame: change from baseline diuresis at 7 days ] [ Designated as safety issue: No ]
    data gathered in the medical file


Secondary Outcome Measures:
  • Readmission [ Time Frame: at 7 days ] [ Designated as safety issue: No ]
    Number of patients with no or having an adverse event during the readmission.

  • Hospitalization in intensive care [ Time Frame: at 7 days ] [ Designated as safety issue: No ]
    Number of patients with no or having an adverse event during the hospitalization in intensive care.

  • Renal replacement [ Time Frame: at 7 days ] [ Designated as safety issue: No ]
    Number of patients with no or having an adverse event during the renal replacement.

  • Death [ Time Frame: at 7 days ] [ Designated as safety issue: Yes ]
    Number of dead


Estimated Enrollment: 500
Study Start Date: December 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   up to 16 Years   (Child)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients less than 16 years and who enjoys receiving an injected CT.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02955979

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

Locations
France
CHU Clermont Ferrand Not yet recruiting
Clermont, France, 63000
Contact: André LABBE, MD PhD    (0)473750050 ext +33      
Principal Investigator: André LABBE, MD PhD         
CHU de Grenoble Not yet recruiting
Grenoble, France, 38700
Contact: Jacques Griffet, MD PhD    (0)476766565 ext +33    jgriffet@chu-grenoble.fr   
Principal Investigator: Jacques Griffet, MD PhD         
Sub-Investigator: Isabelle Wroblewski, MD         
CHU de Lyon Not yet recruiting
Lyon, France, 69310
Contact: Etienne Javouhey, MD PhD    (0)472129735 ext +33    etienne.javouhey@chu-lyon.fr   
Principal Investigator: Etienne Javouhey, MD PhD         
Sub-Investigator: Yves Gillet, MD PhD         
CHU de Nice Not yet recruiting
Nice, France, 06003
Contact: Hervé Hass, MD    (0)492037777 ext +33      
Principal Investigator: Hervé Hass, MD         
Chu Saint-Etienne Recruiting
Saint Etienne, France, 42055
Contact: Olivier MORY, MD    (0)477828632 ext +33    olivier.mory@chu-st-etienne.fr   
Principal Investigator: Olivier MORY, MD         
Sub-Investigator: Aymeric CANTAIS, MD         
Sub-Investigator: Hugues PATURAL, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Olivier MORY, MD CHU SAINT-ETIENNE
  More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02955979     History of Changes
Other Study ID Numbers: 1608041  Y6D1846194a  16-532bis 
Study First Received: October 26, 2016
Last Updated: December 12, 2016
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Ethics Committee
France: Commission nationale de l'informatique et des libertés
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
acute renal insufficiency
Iodinated Contrast Agents
pediatric

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on January 17, 2017