Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

Ospedale Misericordia e Dolce

Status and phase: Completed; Phase 4

Conditions: Contrast Induced Nephropathy

Treatments: Drug: Placebo; Drug: sodium bicarbonate solution; Drug: Isotonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00770614

POCARD0703

Prato0703

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

450 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Drug: sodium bicarbonate solution

2

Active Comparator group

Description:

Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure

Treatment:

Drug: Isotonic saline

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo