Early Hydration in Acute Myocardial Infarction

Ospedale Misericordia e Dolce

Status and phase: Completed; Phase 4

Conditions: Contrast Induced Acute Kidney Injury

Treatments: Drug: Isotonic saline; Drug: sodium bicarbonate solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01742130

Prato0705

Details and patient eligibility

About

The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast nephropathy in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.

Enrollment: 300 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more 1 mm in at least two contiguous leads of electrocardiogram.

Exclusion criteria

• contrast medium administration within the 10 days
• end-stage renal failure requiring dialysis
• refusal to give informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Sodium bicarbonate

Experimental group

Description:

Sodium Bicarbonate (154 mEq/L in dextrose and H2O) 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure

Treatment:

Drug: sodium bicarbonate solution

Saline

Active Comparator group

Description:

Sodium Saline 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure

Treatment:

Drug: Isotonic saline