- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07091656
- Original Trial
Contrast-enhanced Computed Tomography and Acute Kidney Injury
Incidence and Risk Factors of Contrast-associated Acute Kidney Injury in Patients Hospitalised After Contrast-enhanced Computed Tomography in the Emergency Department
Rationale and objectives: Since 1930 it has been accepted that intravenous injection of io-dinated contrast agent as part of contrast-enhanced computed tomography (CE-CT) imaging can induce a contrast-associated acute kidney injury (CA-AKI). For the last 10 years, studies have investigated this iatrogenia. However, those works didn't concern French population and particularly patient hospitalised after emergency department (ED) visit.
This study as-sessed the CA-AKI incidence and factor risks in patients hospitalised after a CE-CT in ED.
This was a retrospective cohort observational study in the ED of the Beaujon University Hospital between October 31st 2019 to January 24th 2022.
Patients over 16 years old who presented to the emergency department and underwent an intravenous contrast-enhanced CT were eligible. To be included, patients were required to have at least two creatinine measurements: one taken within 24 hours before CT and a second measurement taken between 48 hours to the seventh day following the initial test. The CT examination had to be performed at Beaujon Hospital with the injection of iodinated contrast agents such as IOMERON® (iomeprol) or XENETIX® (iobitridol).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Île-de-France (Paris)
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Clichy, Île-de-France (Paris), France, 92110
- Hôpital Beaujon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients over 16 years old who presented to the emergency department and underwent an intravenous contrast-enhanced CT were eligible. To be included, patients were required to have at least two creatinine measurements: one taken within 24 hours before CT and a sec-ond measurement taken between 48 hours to the seventh day following the initial test. The CT examination had to be performed at Beaujon Hospital with the injection of iodinated contrast agents such as IOMERON® (iomeprol) or XENETIX® (iobitridol).
Exclusion Criteria:
- Patients were excluded from the study if they did not have two creatinine measurements meeting the specified criteria. If multiple contrast-enhanced CT examinations were per-formed within a seven-day period for the same patient, only the first examination was in-cluded in the study, while subsequent scans were excluded.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary outcome was the occurrence of CA-AKI defined as KDIGO (Kidney Disease Improval Global Outcomes) tage 1 or higher within seven days after contrast-enhanced CT.
Time Frame: BETWEEN 2 and 7 DAYS ATER CT -SCAN
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BETWEEN 2 and 7 DAYS ATER CT -SCAN
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- urgBjNPC-AKI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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