Back to resultsEarly Hydration in Acute Myocardial Infarction
Primary Purpose
Contrast Induced Acute Kidney Injury
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
sodium bicarbonate solution
Isotonic saline
Sponsored by
About this trial
This is an interventional prevention trial for Contrast Induced Acute Kidney Injury focused on measuring Contrast-induced nephropathy, Contrast media, Angiography, Coronary percutaneous intervention
Eligibility Criteria
Inclusion Criteria:
- Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more 1 mm in at least two contiguous leads of electrocardiogram.
Exclusion Criteria:
- contrast medium administration within the 10 days
- end-stage renal failure requiring dialysis
- refusal to give informed consent
Sites / Locations
- Ospedale Misericordia e Dolce
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sodium bicarbonate
Saline
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
Sodium Saline 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure
Outcomes
Primary Outcome Measures
Incidence of contrast-induced acute kidney injury
contrast-induced acute kidney injury is defined as an increase in serum creatinine >= 0.3 mg/dL over the baseline value within 2 days after the administration of the contrast medium
Secondary Outcome Measures
adverse clinical events
adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration
Full Information
NCT ID
NCT01742130
First Posted
December 2, 2012
Last Updated
November 5, 2013
Sponsor
Ospedale Misericordia e Dolce
1. Study Identification
Unique Protocol Identification Number
NCT01742130
Brief Title
Early Hydration in Acute Myocardial Infarction
Official Title
Early Hydration in Acute Myocardial Infarction: Sodium Bicarbonate Versus Saline for the Prevention on Contrast-induced Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (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 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 Acute Kidney Injury
Keywords
Contrast-induced nephropathy, Contrast media, Angiography, Coronary percutaneous intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium bicarbonate
Arm Type
Experimental
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
Saline
Arm Type
Active Comparator
Arm Description
Sodium Saline 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure
Intervention Type
Drug
Intervention Name(s)
sodium bicarbonate solution
Other Intervention Name(s)
154 mEq/L in dextrose and H2O
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Other Intervention Name(s)
0.9% sodium chloride
Primary Outcome Measure Information:
Title
Incidence of contrast-induced acute kidney injury
Description
contrast-induced acute kidney injury is defined as an increase in serum creatinine >= 0.3 mg/dL over the baseline value within 2 days after the administration of the contrast medium
Time Frame
2 days
Secondary Outcome Measure Information:
Title
adverse clinical events
Description
adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more 1 mm in at least two contiguous leads of electrocardiogram.
Exclusion Criteria:
contrast medium administration within the 10 days
end-stage renal failure requiring dialysis
refusal to give informed consent
Facility Information:
Facility Name
Ospedale Misericordia e Dolce
City
Prato
ZIP/Postal Code
59100
Country
Italy
12. IPD Sharing Statement
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Early Hydration in Acute Myocardial Infarction
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