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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):
University Hospital, Caen

Brief Summary:
The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.

Condition or disease Intervention/treatment Phase
Contrast Induced Acute Kidney Injury Drug: bicarbonates Drug: saline Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : February 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
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%




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01636089     History of Changes
Other Study ID Numbers: 2011-A00227-34
First Posted: July 10, 2012    Key Record Dates
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