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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01742130
Enrollment
300
Registered
2012-12-05
Start date
2011-01-31
Completion date
2013-10-31
Last updated
2013-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Induced Acute Kidney Injury

Keywords

Contrast-induced nephropathy, Contrast media, Angiography, Coronary percutaneous intervention

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.

Interventions

DRUGIsotonic saline

Sponsors

Ospedale Misericordia e Dolce
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of contrast-induced acute kidney injury2 dayscontrast-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

MeasureTime frameDescription
adverse clinical events1 monthadverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026