Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

Ospedale Misericordia e Dolce450 enrolled

Overview

The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast induced nephropathy in patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial Infarction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

450

Conditions

Contrast Induced Nephropathy

Interventions

sodium bicarbonate solutionDRUG

154 mEq/L in dextrose and H2O

Isotonic salineDRUG

0.9% sodium chloride

PlaceboDRUG

Placebo

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention Exclusion Criteria: * refusal to consent * previous contrast exposure within 72 hours

Locations (1)

Ospedale Misericordia e Dolce

Prato, Prato, Italy

Outcomes

Primary Outcomes

Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration

Time frame: within 5 days after contrast exposure

Secondary Outcomes

Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration

Time frame: 1 month

Data from ClinicalTrials.gov

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