Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

Hydration and Contrast-Induced Nephropathy in Primary Angioplasty. A Randomized, Placebo Controlled, Trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00770614

Enrollment

450

Registered

2008-10-10

Start date

2004-03-31

Completion date

2008-12-31

Last updated

2012-05-08

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

Conditions

Contrast Induced Nephropathy

Keywords

Contrast Induced Nephropathy

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 induced nephropathy in patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial Infarction.

Interventions

DRUGsodium bicarbonate solution

154 mEq/L in dextrose and H2O

DRUGIsotonic saline

0.9% sodium chloride

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention

Exclusion criteria

* refusal to consent * previous contrast exposure within 72 hours

Design outcomes

Primary

Measure	Time frame
Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration	within 5 days after contrast exposure

Secondary

Measure	Time frame
Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration	1 month

Countries

Italy

Outcome results

None listed

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