Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

NCT ID: NCT00770614

Last Updated: 2012-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contrast Induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Sodium Bicarbonate (154 mEq/L in dextrose and H2O) 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure

Group Type ACTIVE_COMPARATOR

sodium bicarbonate solution

Intervention Type DRUG

154 mEq/L in dextrose and H2O

2

Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure

Group Type ACTIVE_COMPARATOR

Isotonic saline

Intervention Type DRUG

0.9% sodium chloride

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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sodium bicarbonate solution

154 mEq/L in dextrose and H2O

Intervention Type DRUG

Isotonic saline

0.9% sodium chloride

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention

Exclusion Criteria

* refusal to consent
* previous contrast exposure within 72 hours
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Misericordia e Dolce

OTHER

Sponsor Role lead

Responsible Party

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Mauro Maioli

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mauro Maioli, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Misericordia e Dolce, Prato

Locations

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Ospedale Misericordia e Dolce

Prato, Prato, Italy

Site Status

Countries

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Italy

Other Identifiers

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POCARD0703

Identifier Type: -

Identifier Source: secondary_id

Prato0703

Identifier Type: -

Identifier Source: org_study_id

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