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

Tracking Information
First Received Date ^ICMJE	February 15, 2012
Last Updated Date	February 26, 2013
Start Date ^ICMJE	February 2012
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 5, 2012)	contrast induced acute kidney injury [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01636089 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Contrast Induced Acute Kidney Injury
Intervention ^ICMJE	Drug: bicarbonates sodium bicarbonates 1,4% Drug: saline sodium chloride 0,9%
Study Arm (s)	Experimental: bicarbonates sodium bicarbonates 1,4% Intervention: Drug: bicarbonates Active Comparator: saline sodium chloride 0,9% Intervention: Drug: saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	300
Completion Date	Not Provided
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01636089
Other Study ID Numbers ^ICMJE	2011-A00227-34
Has Data Monitoring Committee	Not Provided
Responsible Party	University Hospital, Caen
Study Sponsor ^ICMJE	University Hospital, Caen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Caen
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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