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Early Hydration in Acute Myocardial Infarction

NCT ID: NCT01742130

Last Updated: 2013-11-07

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-10-31

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 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 Acute Kidney Injury

Keywords

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Contrast-induced nephropathy Contrast media Angiography Coronary percutaneous intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sodium bicarbonate

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 EXPERIMENTAL

sodium bicarbonate solution

Intervention Type DRUG

Saline

Sodium Saline 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

Isotonic saline

Intervention Type DRUG

Interventions

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sodium bicarbonate solution

Intervention Type DRUG

Isotonic saline

Intervention Type DRUG

Other Intervention Names

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154 mEq/L in dextrose and H2O 0.9% sodium chloride

Eligibility Criteria

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Inclusion Criteria

* Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more 1 mm in at least two contiguous leads of electrocardiogram.

Exclusion Criteria

* contrast medium administration within the 10 days
* end-stage renal failure requiring dialysis
* refusal to give informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

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

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

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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Prato0705

Identifier Type: -

Identifier Source: org_study_id