Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

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

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 Overview

• Status: Completed
• Conditions: Contrast Induced Nephropathy
• Intervention / Treatment: Drug: Placebo; Drug: sodium bicarbonate solution; Drug: Isotonic saline

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Prato, Italy, 59100
    • Ospedale Misericordia e Dolce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• refusal to consent
• previous contrast exposure within 72 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3; Placebo	Drug: Placebo; Placebo
Active Comparator: 1; 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	Drug: sodium bicarbonate solution; 154 mEq/L in dextrose and H2O
Active Comparator: 2; Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure	Drug: Isotonic saline; 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ospedale Misericordia e Dolce

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 9, 2008
• First Posted (Estimate): October 10, 2008

Study Record Updates

• Last Update Posted (Estimate): May 8, 2012
• Last Update Submitted That Met QC Criteria: May 6, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Contrast Induced Nephropathy
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: Prato0703; POCARD0703