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Clinical Trials/NCT01172353
NCT01172353
Completed
Phase 3

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

Hospital Sao Lucas da PUCRS1 site in 1 country301 target enrollmentJuly 2004
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ConditionsRenal Failure
Interventionssalinesodium bicarbonate
Drugssodium bicarbonatesaline

Overview

Phase
Phase 3
Intervention
saline
Conditions
Renal Failure
Sponsor
Hospital Sao Lucas da PUCRS
Enrollment
301
Locations
1
Primary Endpoint
Contrast-induced Nephropathy
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2004
End Date
February 2008
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vitor Osorio Gomes

MD, PhD

Hospital Sao Lucas da PUCRS

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

Arms & Interventions

saline

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

Intervention: saline

sodium bicarbonate

hydration with sodium bicarbonate

Intervention: sodium bicarbonate

Outcomes

Primary Outcomes

Contrast-induced Nephropathy

Time Frame: 48 hours

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

Secondary Outcomes

  • Dialysis During Hospitalization(During hospitalization)

Study Sites (1)

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