Variation IGFBP7 Markers and TIMP2 Induced by Injection o... | NCT02881710

Studies
Variation IGFBP7 Markers and TIMP2 Induced by Injection of Contrast Iodized Drug at the Intensive Care Patient

NCT02881710

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Jun 24, 2026Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Emergency

Interventions

contrast product used to assess biomarkers variations

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

Aug 2016

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

Apr 9, 2014Actual

Primary Completion Date

Mar 27, 2016Actual

Completion Date

Mar 27, 2016Actual

First Submitted Date

Aug 24, 2016

First Submission Date that Met QC Criteria

Aug 26, 2016

First Posted Date

Aug 29, 2016Estimated

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

Jun 23, 2026

Last Update Posted Date

Jun 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Multicenter, prospective, uncontrolled study to evaluate variations in urinary concentrations of TIMP-2 and PCI IGFBP7 induced injection during a CT scan in intensive care patient.

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

50Actual

Name	Type	Description	Arm Group Labels	Other Names
contrast product used to assess biomarkers variations	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
significant increase in urinary concentrations of TIMP-2 and IGFBP7 defined as an increase of NephroCheck® test of more than 0.2 [ng / mL] 2/1000) after PCI injection		follow up: 5 days after injection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18 years or more,
Hospitalized in intensive care,
Holders of a urinary catheter
Patient receiving a first CT with intravenous injection of PCI during their ICU stay.
Patient agreeing to participate in the research protocol

Exclusion Criteria:

Anuria
Need to retain urine, whatever the reason (eg measurement of 24-hour proteinuria).
Urine unanalyzable whatever reason (eg urinary washing with double current probe, injection is saline to measure bladder pressure.).
Patient subjected to renal replacement
Patient already included in the study for a previous injection of PCI in intensive care.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Medical and surgical intensive care adult patients undergoing CT with PCI intravenous injection.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nantes		Nantes		44093	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided