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

Azienda USL Reggio Emilia - IRCCS

Status and phase: Completed; Phase 4

Conditions: Contrast Induced Nephropathy

Treatments: Drug: sodium bicarbonate; Drug: sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00639912

MAN1374

Details and patient eligibility

About

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.

Full 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.

Enrollment: 599 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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599 participants in 4 patient groups

A: low volume saline

Active Comparator group

Description:

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.

Treatment:

Drug: sodium chloride

Drug: sodium chloride

B: high volume saline

Active Comparator group

Description:

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.

Treatment:

Drug: sodium chloride

Drug: sodium chloride

C: low volume sodium bicarbonate

Active Comparator group

Description:

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.

Treatment:

Drug: sodium bicarbonate

Drug: sodium bicarbonate

D: high volume sodium bicarbonate

Active Comparator group

Description:

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.

Treatment:

Drug: sodium bicarbonate

Drug: sodium bicarbonate