Phase 3 N=301 Randomized Single-blind Prevention

Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

Renal Failure

Bottom Line

View on ClinicalTrials.gov: NCT01172353 ↗

Enrolled (actual)

301

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcome: Primary: Contrast-induced Nephropathy — 6.1; 6.0 percentage of contrast nephropaty

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: sodium bicarbonate (Drug); saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital Sao Lucas da PUCRS
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Contrast-induced Nephropathy	6.1; 6.0	—
SECONDARY Dialysis During Hospitalization	0; 0	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01172353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.