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

Last updated: June 6, 2025
Sponsor: Azienda USL Reggio Emilia - IRCCS
Overall Status: Completed

Phase

4

Condition

Angina

Cardiac Disease

Congestive Heart Failure

Treatment

sodium chloride

sodium bicarbonate

Clinical Study ID

NCT00639912
MAN1374
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years of years

  • Chest pain lasting at least 30 minutes, non responsive to nitrates, associated to STelevation of at least 0.2 mV on surface ECG in two or more contiguous leads or tonew left bundle branch block.

  • Informed consent

Exclusion

Exclusion Criteria:

  • Chronic hemodialytic or peritoneal treatment

  • Coronary anatomy unsuitable for PCI

  • Need of emergency coronary artery by-pass grafting

  • Post-anoxic coma

  • Pregnancy

Study Design

Total Participants: 599
Treatment Group(s): 2
Primary Treatment: sodium chloride
Phase: 4
Study Start date:
June 01, 2007
Estimated Completion Date:
October 31, 2010

Study Description

Contrast-induced nephropathy (CIN) is associated with increased morbidity and mortality after percutaneous coronary interventions (PCI). Patients with ST elevation myocardial infarction (STEMI) are at high risk for CIN because of hemodynamic instability of the patient, inability to prevent the phenomenon (hydration) and the possible exposure to high volume of contrast media. Recent reports have shown incidence of CIN up to 19% in this population and a related increase of in-hospital mortality.

Merten e coll. (JAMA 2004) reported that sodium bicarbonate infusion before and after contrast exposure in patients with chronic renal failure and without myocardial infarction (AMI) is more effective than sodium chloride in preventing CIN.

Up to date there is no evidence of any effective prophylactic measures in patients with STEMI undergoing primary PCI.

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

The infusion of the randomized solution will start just after randomization and after determination of baseline serum creatinine.

Determination of serum creatinine will be repeated at 24, 48 and 72 hours after randomization. Creatinine clearance will be calculated with Cockroft-Gault formula and MDRD.

Connect with a study center

  • Nuovo Ospedale Civile di Baggiovara

    Modena, Emilia-Romagna 41100
    Italy

    Site Not Available

  • Arcispedale S. Maria Nuova

    Reggio Emilia, Emilia-Romagna 42100
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria S. Anna

    Ferrara, Emilia-romagna
    Italy

    Site Not Available

  • Dipartimento di Cardiologia, Ospedale di Lavagna

    Lavagna, Genova 16033
    Italy

    Site Not Available

  • Dipartimento di Cardiologia, Ospedale Maggiore

    Parma, 43100
    Italy

    Site Not Available

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