Trial | NCT01172353  Report issue

Title

Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy
Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Study Participants

    301
The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.
Study Started
Jul 31
2004
Primary Completion
Jan 31
2008
Study Completion
Feb 29
2008
Results Posted
Feb 19
2014
Estimate
Last Update
Feb 19
2014
Estimate

Drug sodium bicarbonate

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

Drug saline

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

sodium bicarbonate Experimental

hydration with sodium bicarbonate

saline Active Comparator

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

Criteria 

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

Summary

Sodium Bicarbonate

Saline

All Events

Event Type Organ System Event Term

Contrast-induced Nephropathy

rise in serum creatinine >0,5mg/dl

Sodium Bicarbonate

6.1
percentage of contrast nephropaty

Saline

6.0
percentage of contrast nephropaty

Dialysis During Hospitalization

Sodium Bicarbonate

Saline

Total

301
Participants

Age, Continuous

64.3
years (Mean)
Standard Deviation: 12

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

Sodium Bicarbonate

Saline