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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Caen Identifier:
First received: February 15, 2012
Last updated: February 2, 2015
Last verified: February 2015
The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.

Condition Intervention Phase
Contrast Induced Acute Kidney Injury
Drug: bicarbonates
Drug: saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • contrast induced acute kidney injury [ Time Frame: 72 hours ]

Enrollment: 300
Study Start Date: February 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bicarbonates
sodium bicarbonates 1,4%
Drug: bicarbonates
sodium bicarbonates 1,4%
Active Comparator: saline
sodium chloride 0,9%
Drug: saline
sodium chloride 0,9%


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01636089

Medical Intensive Care Unit
Caen, France, 14033
Surgical Intensive Care Unit
Caen, France, 14033
Intensive care unit
Saint Lô, France, 50000
Sponsors and Collaborators
University Hospital, Caen
  More Information

Responsible Party: University Hospital, Caen Identifier: NCT01636089     History of Changes
Other Study ID Numbers: 2011-A00227-34
Study First Received: February 15, 2012
Last Updated: February 2, 2015

Keywords provided by University Hospital, Caen:
intensive care unit

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases processed this record on April 25, 2017