Trial | NCT00770614  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    450
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.
Study Started
Mar 31
2004
Primary Completion
Jun 30
2008
Study Completion
Dec 31
2008
Last Update
May 08
2012
Estimate

Drug sodium bicarbonate solution

154 mEq/L in dextrose and H2O

Drug Isotonic saline

0.9% sodium chloride

Drug Placebo

Placebo

1 Active Comparator

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

2 Active Comparator

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

3 Placebo Comparator

Placebo

Criteria 

Inclusion Criteria:

patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention

Exclusion Criteria:

refusal to consent
previous contrast exposure within 72 hours
No Results Posted