Early Hydration in Acute Myocardial Infarction

Phase 4

Completed

• Conditions: Contrast Induced Acute Kidney Injury
• Interventions: Drug: Isotonic saline; Drug: sodium bicarbonate solution

• Registration Number: NCT01742130
• Lead Sponsor: Ospedale Misericordia e Dolce

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-12-02
• Study First Submitted QC: 2012-12-02
• Study First Posted: 2012-12-05
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Isotonic saline	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
Sodium bicarbonate	sodium bicarbonate solution	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

Primary Outcome Measures

Name	Time	Method
Incidence of contrast-induced acute kidney injury	2 days	contrast-induced acute kidney injury is defined as an increase in serum creatinine \>= 0.3 mg/dL over the baseline value within 2 days after the administration of the contrast medium

Secondary Outcome Measures

Name	Time	Method
adverse clinical events	1 month	adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration

Trial Locations

Locations (1)

Ospedale Misericordia e Dolce; 🇮🇹 Prato, Italy