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Effects of Hydration to Prevent Contrast Induced Nephropathy in PCI for ST-elevation Myocardial Infarction.

NCT00639912 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 599

Last updated 2025-06-11

No results posted yet for this study

Summary

The aim of the study is to test the efficacy of low versus high volume hydration and two different solutions (sodium chloride versus sodium bicarbonate) in preventing contrast induced nephropathy (CIN) in ST elevation myocardial infarction (STEMI) patients undergoing primary PCI.

Conditions

  • Contrast Induced Nephropathy

Interventions

DRUG

sodium chloride

Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/Kg/hour for 12 hours.

DRUG

sodium chloride

Solution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours

DRUG

sodium bicarbonate

154 mEq/L of sodium bicarbonate in dextrose solution. Rate of infusion: 1 ml/Kg/hour for 12 hours.

DRUG

sodium bicarbonate

154 mEq/L of sodium chloride in dextrose solution. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours.

Sponsors & Collaborators

  • Azienda Sanitaria Ospedaliera

    collaborator OTHER

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Principal Investigators

  • Antonio Manari, MD · Arcispedale S. Maria Nuova Reggio Emilia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-05-31
Completion
2010-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00639912 on ClinicalTrials.gov