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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01636089
First received: February 15, 2012
Last updated: February 2, 2015
Last verified: February 2015

February 15, 2012
February 2, 2015
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
Not Provided

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.
 
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01636089
2011-A00227-34
Not Provided
University Hospital, Caen
University Hospital, Caen
Not Provided
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