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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

July 28, 2010
January 7, 2014
July 2004
January 2008   (final data collection date for primary outcome measure)
Contrast-induced Nephropathy [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
rise in serum creatinine >0,5mg/dl
Same as current
Complete list of historical versions of study NCT01172353 on ClinicalTrials.gov Archive Site
Dialysis During Hospitalization [ Time Frame: During hospitalization ] [ Designated as safety issue: No ]
  • dialysis during hospitalization [ Designated as safety issue: No ]
  • length of hospitalization [ Designated as safety issue: No ]
  • in-hospital mortality [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy
Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial

The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Renal Failure
  • Drug: sodium bicarbonate
    hydration with sodium bicarbonate 1ml/Kg/h for 6 hours
  • Drug: saline
    hydration with saline 1ml/Kg/h for 6 hours
  • Experimental: sodium bicarbonate
    hydration with sodium bicarbonate
    Intervention: Drug: sodium bicarbonate
  • Active Comparator: saline
    hydration with saline 1ml/Kg/h for 6 hours
    Intervention: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
301
February 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • serum creatinine > 1.1 mg/dL
  • glomerular filtration rate (GFR) < 50 mL/min

Exclusion Criteria:

  • age < 18 years
  • use of radiographic contrast media during the last 21 days
  • history of dialysis
  • cardiac insufficiency class III-IV
  • emergency procedures
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01172353
HSaoLucas
Not Provided
Vitor Osorio Gomes, Hospital Sao Lucas da PUCRS
Hospital Sao Lucas da PUCRS
Not Provided
Not Provided
Hospital Sao Lucas da PUCRS
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP