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

Completed

• Conditions: Acute Myocardial Infarction; Acute Kidney Injury
• Interventions: Drug: Sodium bicarbonate plus NAC; Drug: Saline hydration plus NAC

• Registration Number: NCT01218178
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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.

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sodium bicarbonate plus NAC	Sodium bicarbonate plus NAC	Sodium bicarbonate plus NAC
Saline hydration plus NAC	Saline hydration plus NAC	Saline hydration plus NAC

Primary Outcome Measures

Name	Time	Method
All cause mortality, contrast-induced nephropathy and need of dialysis.	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.

Trial Locations

Locations (1)

Policlinico Agostino Gemelli and Policlinico Casilino; 🇮🇹 Rome, Italy