Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy

Ospedale Misericordia e Dolce

Status and phase: Completed; Phase 4

Conditions: Contrast-Induced Nephropathy

Treatments: Drug: Sodium Bicarbonate; Drug: Isotonic Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00606827

Prato0701

POCARD0701

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

A

Experimental group

Description:

Bicarbonate

Treatment:

Drug: Sodium Bicarbonate

B

Active Comparator group

Description:

Saline

Treatment:

Drug: Isotonic Saline