Hydration and Contrast-Induced Nephropathy in Primary Angioplasty
Primary Purpose
Contrast Induced Nephropathy
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
sodium bicarbonate solution
Isotonic saline
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring Contrast Induced Nephropathy
Eligibility 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
Sites / Locations
- Ospedale Misericordia e Dolce
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm 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
Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure
Placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration
Full Information
NCT ID
NCT00770614
First Posted
October 9, 2008
Last Updated
May 6, 2012
Sponsor
Ospedale Misericordia e Dolce
1. Study Identification
Unique Protocol Identification Number
NCT00770614
Brief Title
Hydration and Contrast-Induced Nephropathy in Primary Angioplasty
Official Title
Hydration and Contrast-Induced Nephropathy in Primary Angioplasty. A Randomized, Placebo Controlled, Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Misericordia e Dolce
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
Keywords
Contrast Induced Nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm 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
Arm Title
2
Arm Type
Active Comparator
Arm Description
Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
sodium bicarbonate solution
Intervention Description
154 mEq/L in dextrose and H2O
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Intervention Description
0.9% sodium chloride
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Time Frame
within 5 days after contrast exposure
Secondary Outcome Measure Information:
Title
Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Maioli, MD
Organizational Affiliation
Ospedale Misericordia e Dolce, Prato
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Misericordia e Dolce
City
Prato
ZIP/Postal Code
59100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Hydration and Contrast-Induced Nephropathy in Primary Angioplasty
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