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Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit (HYDRAREA)

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ClinicalTrials.gov Identifier: NCT01636089
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):

February 15, 2012
July 10, 2012
February 3, 2015
February 2012
January 2015   (Final data collection date for primary outcome measure)
contrast induced acute kidney injury [ Time Frame: 72 hours ]
Same as current
Complete list of historical versions of study NCT01636089 on ClinicalTrials.gov Archive Site
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Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit
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The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.
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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Contrast Induced Acute Kidney Injury
  • Drug: bicarbonates
    sodium bicarbonates 1,4%
  • Drug: saline
    sodium chloride 0,9%
  • Experimental: bicarbonates
    sodium bicarbonates 1,4%
    Intervention: Drug: bicarbonates
  • Active Comparator: saline
    sodium chloride 0,9%
    Intervention: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
January 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patient > 18 years old
  • in intensive care unit since 24h and for up to 48 hours
  • with contrast medium injection

Exclusion Criteria:

  • patient under renal replacement therapy
  • rise in creatinine > 26µmol/L within 48hours
  • anuria within 12 hours
  • cardiogenic pulmonary oedema
  • pH > 7.50 or kaliemia < 3mmol/L
  • pregnancy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01636089
2011-A00227-34
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University Hospital, Caen
University Hospital, Caen
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Not Provided
University Hospital, Caen
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP