Early Hydration in Acute Myocardial Infarction

Contrast Induced Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742130
• Other study ID #: Prato0705
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2012
• Last updated: November 5, 2013
• Start date: January 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Ospedale Misericordia e Dolce
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast Induced Acute Kidney Injury
• Myocardial Infarction

Intervention

Drug:
• sodium bicarbonate solution

• Isotonic saline

Locations

Country	Name	City	State
Italy	Ospedale Misericordia e Dolce	Prato

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Misericordia e Dolce

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	adverse clinical events	adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration	1 month	Yes