Early Hydration in Acute Myocardial Infarction

Early Hydration in Acute Myocardial Infarction: Sodium Bicarbonate Versus Saline for the Prevention on Contrast-induced Acute Kidney Injury

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.

Study Overview

• Status: Completed
• Conditions: Contrast Induced Acute Kidney Injury
• Intervention / Treatment: Drug: Isotonic saline; Drug: sodium bicarbonate solution

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Prato, Italy, 59100
    • Ospedale Misericordia e Dolce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sodium bicarbonate; 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	Drug: sodium bicarbonate solution; Other Names: 154 mEq/L in dextrose and H2O
ACTIVE_COMPARATOR: 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	Drug: Isotonic saline; Other Names: 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of contrast-induced acute kidney injury	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	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse clinical events	adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration	1 month

Collaborators and Investigators

• Sponsor: Ospedale Misericordia e Dolce

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: December 2, 2012
• First Submitted That Met QC Criteria: December 2, 2012
• First Posted (ESTIMATE): December 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 7, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Contrast-induced nephropathy; Angiography; Contrast media; Coronary percutaneous intervention
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Myocardial Infarction; Infarction; Acute Kidney Injury
• Other Study ID Numbers: Prato0705