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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Caen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01636089
First received: February 15, 2012
Last updated: April 8, 2014
Last verified: April 2014

February 15, 2012
April 8, 2014
February 2012
January 2015   (final data collection date for primary outcome measure)
contrast induced acute kidney injury [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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.
 
Recruiting
300
Not Provided
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
Both
18 Years and older
No
France
 
NCT01636089
2011-A00227-34
Not Provided
University Hospital, Caen
University Hospital, Caen
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Not Provided
University Hospital, Caen
April 2014

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