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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Misericordia e Dolce | Prato |
Lead Sponsor | Collaborator |
---|---|
Ospedale Misericordia e Dolce |
Italy,
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 |
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