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

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ClinicalTrials.gov Identifier: NCT02881710
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : August 29, 2016
Sponsor:
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 ]


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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.
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.

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov 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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Emergencies
Disease Attributes
Pathologic Processes