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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636089
First Posted: July 10, 2012
Last Update Posted: February 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Caen
  Purpose
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 (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%

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636089


Locations
France
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
ClinicalTrials.gov Identifier: NCT01636089     History of Changes
Other Study ID Numbers: 2011-A00227-34
First Submitted: February 15, 2012
First Posted: July 10, 2012
Last Update Posted: February 3, 2015
Last Verified: February 2015

Keywords provided by University Hospital, Caen:
intensive care unit

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases