Clinical Trials/NCT00606827

NCT00606827

Completed

Phase 4

Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy in Patients Undergoing Coronary Angiography

Ospedale Misericordia e Dolce1 site in 1 country500 target enrollmentJanuary 2005

ConditionsContrast-Induced Nephropathy

InterventionsSodium Bicarbonate Isotonic Saline

DrugsSodium Bicarbonate Isotonic Saline

Overview

Phase: Phase 4
Intervention: Sodium Bicarbonate
Conditions: Contrast-Induced Nephropathy
Sponsor: Ospedale Misericordia e Dolce
Enrollment: 500
Locations: 1
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal failure. Hydration with sodium bicarbonate is more protective than isotonic saline in animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate versus isotonic saline to prevent CIN in a large population of patients with renal dysfunction undergoing coronary angiography or intervention.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

March 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ospedale Misericordia e Dolce

Responsible Party

Principal Investigator

Principal Investigator

Mauro Maioli

MD

Ospedale Misericordia e Dolce

Eligibility Criteria

Inclusion Criteria

•patients with creatinine clearance \< 60 mL/min

Exclusion Criteria

•contrast medium administration within the previous 10 days
•end-stage renal failure requiring dialysis
•refusal to give informed consent

Arms & Interventions

A

Bicarbonate

Intervention: Sodium Bicarbonate

B

Saline

Intervention: Isotonic Saline

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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