Sodium Bicarbonate and N-Acetylcysteine for Nephroprotection in Acute Myocardial Infarction (BINARIO)

March 12, 2015 updated by: Antonio Maria Leone, Catholic University of the Sacred Heart

BIcarbonato di Sodio e N-Acetilcisteina Nella Prevenzione Della Nefropatia da Mezzo di Contrasto Nell'infaRto mIocardico acutO(Registro BINARIO)

Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and therapeutic procedures in interventional cardiology, especially in the acute setting of primary PCI. The investigators will test the efficacy of sodium bicarbonate (NaHCO3) and N-acetylcysteine (NAC) on the prevention of acute events and CIN in patients with acute myocardial infarction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Contrast-induced nephropathy (CIN) represents a potential complication of diagnostic and therapeutic procedures in interventional cardiology. In the setting of elective procedures, the strategy of sodium bicarbonate (NaHCO3) and N-acetylcysteine (NAC) infusion has been shown to reduce the incidence of CIN in high-risk patients. The efficacy of this strategy has not been demonstrated in the case of primary percutaneous coronary intervention (PCI).

Aim of the study The aim is to assess the efficacy of the strategy of sodium bicarbonate 154mEq/l + glucose solution 5% (infusion rate: 3 mL • kg-1 • h-1 for 1 hour followed by 1 mL • kg-1 • h-1 for 6 hours) and NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours) in reducing the incidence of CIN in patients with STEMI undergoing primary or rescue PCI. As control group, a population of STEMI patients treated with NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours) + conventional hydration with saline solution 0.9% will be retrospectively enrolled. According to the common definition, CIN will be defined as increase of the level of serum creatinine >0,5 mg/dL and/or increase ≥25% serum creatinine and/or decrease ≥25% of the glomerular filtration rate (GFR) as calculated with the MDRD Modification of Diet in Renal Disease)formula at 48 hours after PCI compared with baseline value after primary PCI.

Study Design This is a two-center (Policlinico Gemelli and Policlinico Casilino, Rome, Italy), prospective, spontaneous (not sponsored) observational study.

Patient population

Inclusion criteria:

  • Consecutive patients with ST-Segment Elevation Myocardial Infarction (STEMI) as diagnosed according to the ACC (American College of Cardiology) criteria:

    • ischemic symptoms;
    • ECG variations: ST-elevation (>0,05 mV) in two or more contiguous leads;
    • Increase of the biochemical markers of myocardial necrosis (troponin T, cTNT).
  • Indication to urgent coronary angiography and primary or rescue PCI

Exclusion criteria:

  • Patients with history of allergic reaction to NAC (Fluimucil, Zambon Group Spa, Milan, Italy)
  • Chronic hemodialysis
  • Age > 90 years

Study protocol Patients will be treated with 154 mEq/L of sodium bicarbonate and glucose 5% solution (infusion rate of 3 mL • kg-1 • h-1 for 1 hour followed by 1 mL • kg-1 • h-1 for 6 hours) plus NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours). As control group, a population of STEMI patients treated with conventional hydration with saline solution 0,9% and NAC (1200 mg i.v. followed by 1200 mg bid for the next 48 hours) according to the common clinical practice of the Department of Cardiovascular Medicine of the Policlinico Agostino Gemelli and of Cardiology Department of the Policlinico Casilino will be retrospectively enrolled.

Endpoints:

Primary endpoint:

- Composite endpoint (death/need for dialysis/CIN)

Secondary endpoints:

  • assessment of individual major adverse events (death, re-infarction, need for dialysis) during at 1, 6 and 12 months
  • assessment of the incidence of CIN defined as increase of the level of serum creatinine >0,5 mg/dL and/or increase ≥25% serum creatinine and/or decrease ≥25% of the glomerular filtration rate (GFR) as calculated with the MDRD formula at 48 hours after PCI compared with baseline value.

Study Type

Observational

Enrollment (Actual)

520

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
      • Rome, Italy, 00168
        • Policlinico Agostino Gemelli and Policlinico Casilino

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

14 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

• Consecutive patients admitted from ER of the Policlinico Agostino Gemelli and Casilino of Rome with a ST-Segment Elevation Myocardial Infarction undergoing urgent PCI

Description

Inclusion Criteria:

  • ST-Segment Elevation Myocardial Infarction (STEMI) as diagnosed according to the ACC (American College of Cardiology) criteria:
  • ischemic symptoms;
  • ECG variations: ST-elevation (>0,05 mV) in two or more contiguous leads;
  • Increase of the biochemical markers of myocardial necrosis (troponin T, cTNT). • Indication to urgent coronary angiography and primary or rescue PCI

Exclusion Criteria:

  • Patients with history of allergic reaction to NAC
  • Chronic hemodialysis
  • Age >= 90 years

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

  • Observational Models: Case-Control

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sodium bicarbonate plus NAC
Drug: Sodium bicarbonate plus NAC
154 mEq/L sodium bicarbonate (infusion rate of 3 ml/Kg for 1 hour followed by 1 ml/Kg for 6 hours) plus NAC (1200 mg bid for 48 hours)
Saline hydration plus NAC
Drug: Saline hydration plus NAC
0.9% saline (1 ml/Kg for 12 hours) plus NAC (1200 mg bid for 48 hours)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality, contrast-induced nephropathy and need of dialysis.
Time Frame: 2010
To test the efficacy of sodium bicarbonate plus N-acetylcysteine vs saline hydration plus N-acetylcysteine to reduce mortality and to prevent contrast-induced nephropathy in the setting of primary PCI.
2010

Collaborators and Investigators

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

Sponsor

Catholic University of the Sacred Heart

Collaborators

Policlinico Casilino ASL RMB

Investigators

  • Principal Investigator: Antonio Maria Leone, MD, PhD, Catholic University of the Sacred Heart, Rome

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, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Estimate)

March 13, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/479/CE/2010

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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