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

November 29, 2010 updated by: Arcispedale Santa Maria Nuova-IRCCS

Randomized Trial on the Effects of Hydration With Sodium Chloride Versus Sodium Bicarbonate to Prevent Contrast Induced Nephropathy, in Patients Undergoing Primary Coronary Interventions for Acute ST Elevation Myocardial Infarction.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

599

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43100
        • Dipartimento di Cardiologia, Ospedale Maggiore
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
        • Nuovo Ospedale Civile di Baggiovara
      • Reggio Emilia, Emilia-Romagna, Italy, 42100
        • Arcispedale S. Maria Nuova
    • Emilia-romagna
      • Ferrara, Emilia-romagna, Italy
        • Azienda Ospedaliera Universitaria S. Anna
    • Genova
      • Lavagna, Genova, Italy, 16033
        • Dipartimento di Cardiologia, Ospedale di Lavagna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years of years
  • Chest pain lasting at least 30 minutes, non responsive to nitrates, associated to ST elevation of at least 0.2 mV on surface ECG in two or more contiguous leads or to new left bundle branch block.
  • Informed consent

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: low volume saline
Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/kg/hour for 12 hours after the procedure, starting in the Cath Lab.
Drug: sodium chloride
Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/Kg/hour for 12 hours.
Other Names:
  • Normal saline. Isotonic saline. Sodium chloride 0.9% .
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
Other Names:
  • Normal saline. Isotonic saline. Sodium Chloride 0.9% .
Active Comparator: B: high volume saline
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 after the procedure, starting in the Cath lab.
Drug: sodium chloride
Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/Kg/hour for 12 hours.
Other Names:
  • Normal saline. Isotonic saline. Sodium chloride 0.9% .
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
Other Names:
  • Normal saline. Isotonic saline. Sodium Chloride 0.9% .
Active Comparator: C: low volume sodium bicarbonate
Solution of 154 mEq/L of sodium bicarbonate. Rate of infusion: 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath Lab.
Drug: sodium bicarbonate
154 mEq/L of sodium bicarbonate in dextrose solution. Rate of infusion: 1 ml/Kg/hour for 12 hours.
Other Names:
  • Addition of 77 ml 8,4% Na bicarbonate to 423 ml 5% dextrose.
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.
Other Names:
  • Addition of 77 ml 8,4% Na bicarbonate to 423 ml 5% dextrose.
Active Comparator: D: high volume sodium bicarbonate
Solution of 154 mEq/L of sodium bicarbonate. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath Lab.
Drug: sodium bicarbonate
154 mEq/L of sodium bicarbonate in dextrose solution. Rate of infusion: 1 ml/Kg/hour for 12 hours.
Other Names:
  • Addition of 77 ml 8,4% Na bicarbonate to 423 ml 5% dextrose.
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.
Other Names:
  • Addition of 77 ml 8,4% Na bicarbonate to 423 ml 5% dextrose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
contrast induced nephropathy incidence
Time Frame: 24, 48 and 72 hours
24, 48 and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcispedale Santa Maria Nuova-IRCCS

Collaborators

Azienda Sanitaria Ospedaliera

Investigators

  • Principal Investigator: Antonio Manari, MD, Arcispedale S. Maria Nuova Reggio Emilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

November 30, 2010

Last Update Submitted That Met QC Criteria

November 29, 2010

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAN1374

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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