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Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01172353
Enrollment
301
Registered
2010-07-29
Start date
2004-07-31
Completion date
2008-02-29
Last updated
2014-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure

Keywords

contras-induced nephropathy

Brief 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.

Interventions

DRUGsodium bicarbonate

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

DRUGsaline

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

Sponsors

Hospital Sao Lucas da PUCRS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Contrast-induced Nephropathy48 hoursrise in serum creatinine \>0,5mg/dl

Secondary

MeasureTime frame
Dialysis During HospitalizationDuring hospitalization

Countries

Brazil

Participant flow

Participants by arm

ArmCount
Sodium Bicarbonate
hydration with sodium bicarbonate sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours
150
Saline
hydration with saline 1ml/Kg/h for 6 hours saline: hydration with saline 1ml/Kg/h for 6 hours
151
Total301

Baseline characteristics

CharacteristicSodium BicarbonateTotalSaline
Age, Continuous64.1 years
STANDARD_DEVIATION 12
64.3 years
STANDARD_DEVIATION 12
64.5 years
STANDARD_DEVIATION 12
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants21 Participants11 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
140 Participants280 Participants140 Participants
Region of Enrollment
Brazil
150 participants301 participants151 participants
Sex: Female, Male
Female
46 Participants84 Participants38 Participants
Sex: Female, Male
Male
104 Participants217 Participants113 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1500 / 151
serious
Total, serious adverse events
0 / 1500 / 151

Outcome results

Primary

Contrast-induced Nephropathy

rise in serum creatinine \>0,5mg/dl

Time frame: 48 hours

ArmMeasureValue (NUMBER)
Sodium BicarbonateContrast-induced Nephropathy6.1 percentage of contrast nephropaty
SalineContrast-induced Nephropathy6.0 percentage of contrast nephropaty
Secondary

Dialysis During Hospitalization

Time frame: During hospitalization

ArmMeasureValue (NUMBER)
Sodium BicarbonateDialysis During Hospitalization0 participants
SalineDialysis During Hospitalization0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026