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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02881710
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : August 29, 2016
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment
Emergency Other: contrast product used to assess biomarkers variations

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Variation IGFBP7 Markers and TIMP2 Induced by Injection of Contrast Iodized Drug at the Intensive Care Patient
Study Start Date : December 2014
Actual Primary Completion Date : March 2016

Primary Outcome Measures :
  1. 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 [ Time Frame: follow up: 5 days after injection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Medical and surgical intensive care adult patients undergoing CT with PCI intravenous injection.

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.

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Responsible Party: Nantes University Hospital Identifier: NCT02881710     History of Changes
Other Study ID Numbers: RC14_0241
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes