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NCT02881710 Clinical Trial

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

Emergency Clinical Trial

— ContraCHECK  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02881710
Other study ID # RC14_0241
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 9, 2014
Est. completion date March 27, 2016

Study information
Verified date August 2016
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 27, 2016
Est. primary completion date March 27, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• contrast product used to assess biomarkers variations

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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