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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.
Verified February 2013 by University Hospital, Caen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01636089
First received: February 15, 2012
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Primary Completion Date: February 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636089

Locations
France
Medical Intensive Care Unit Recruiting
Caen, France, 14033
Contact: Xavier Valette, MD     33 2 31 06 47 16     valette-x@chu-caen.fr    
Contact: Damien du Cheyron, MD PhD     33 2 31 06 47 16     ducheyron-d@chu-caen.fr    
Principal Investigator: Xavier Valette, MD            
Surgical Intensive Care Unit Recruiting
Caen, France, 14033
Contact: Jean Luc Hanouz, MD PhD     33 2 31 06 31 06     hanouz-jl@chu-caen.fr    
Principal Investigator: Jean Luc Hanouz, MD PhD            
Sponsors and Collaborators
University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01636089     History of Changes
Other Study ID Numbers: 2011-A00227-34
Study First Received: February 15, 2012
Last Updated: February 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
intensive care unit

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

ClinicalTrials.gov processed this record on May 16, 2013