Contrast-enhanced Computed Tomography and Acute Kidney In... | NCT07091656

Studies
Contrast-enhanced Computed Tomography and Acute Kidney Injury

NCT07091656

Sponsor

Beaujon Hospital

Status

Completed

Last Update Posted

Jul 29, 2025Actual

Enrollment

1,463Actual

Phase

Not provided

Conditions

Contrast-associated Acute Kidney Injury

Interventions

there is no intervention

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2019Actual

Primary Completion Date

Jan 24, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jul 22, 2025

First Submission Date that Met QC Criteria

Jul 22, 2025

First Posted Date

Jul 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2025

Last Update Posted Date

Jul 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,463Actual

Name	Type	Description	Arm Group Labels	Other Names
there is no intervention	Other	NO INTERVENTION

Outcomes Module

Primary Outcomes

Measure	Description	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.		BETWEEN 2 and 7 DAYS ATER CT -SCAN

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients over 16 years old who presented to the emergency department and underwent an intravenous contrast-enhanced CT were eligible.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Beaujon		Clichy	Île-de-France (Paris)	92110	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41462065	Derived	Lecomte E, Vaittinada Ayar P, Vilgrain V, Vaittinada Ayar P. Incidence and risk factors of contrast-associated acute kidney injury in patients hospitalised after contrast-enhanced computed tomography in the emergency department. Int J Emerg Med. 2025 Dec 29;18(1):265. doi: 10.1186/s12245-025-01058-0.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases