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Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vitor Osorio Gomes, Hospital Sao Lucas da PUCRS
ClinicalTrials.gov Identifier:
NCT01172353
First received: July 28, 2010
Last updated: January 7, 2014
Last verified: January 2014
Results First Received: January 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Renal Failure
Interventions: Drug: sodium bicarbonate
Drug: saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sodium Bicarbonate

hydration with sodium bicarbonate

sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours

Saline

hydration with saline 1ml/Kg/h for 6 hours

saline: hydration with saline 1ml/Kg/h for 6 hours


Participant Flow:   Overall Study
    Sodium Bicarbonate   Saline
STARTED   150   151 
COMPLETED   150   151 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sodium Bicarbonate

hydration with sodium bicarbonate

sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours

Saline

hydration with saline 1ml/Kg/h for 6 hours

saline: hydration with saline 1ml/Kg/h for 6 hours

Total Total of all reporting groups

Baseline Measures
   Sodium Bicarbonate   Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   151   301 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.1  (12)   64.5  (12)   64.3  (12) 
Gender 
[Units: Participants]
     
Female   46   38   84 
Male   104   113   217 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   10   11   21 
White   140   140   280 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Brazil   150   151   301 


  Outcome Measures
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1.  Primary:   Contrast-induced Nephropathy   [ Time Frame: 48 hours ]

2.  Secondary:   Dialysis During Hospitalization   [ Time Frame: During hospitalization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vitor Osório Gomes, MD, PhD
Organization: Hospital Sao Lucas
phone: 55 51 33203494
e-mail: pesquisa@cardiarte.com.br



Responsible Party: Vitor Osorio Gomes, Hospital Sao Lucas da PUCRS
ClinicalTrials.gov Identifier: NCT01172353     History of Changes
Other Study ID Numbers: HSaoLucas
Study First Received: July 28, 2010
Results First Received: January 7, 2014
Last Updated: January 7, 2014
Health Authority: Brazil: National Committee of Ethics in Research