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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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  
Number of Participants  
[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


No publications provided


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