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Early Hydration in Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01742130
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : November 7, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Contrast Induced Acute Kidney Injury Drug: sodium bicarbonate solution Drug: Isotonic saline Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Hydration in Acute Myocardial Infarction: Sodium Bicarbonate Versus Saline for the Prevention on Contrast-induced Acute Kidney Injury
Study Start Date : January 2011
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sodium bicarbonate
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
Other Name: 154 mEq/L in dextrose and H2O
Active Comparator: Saline
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
Drug: Isotonic saline
Other Name: 0.9% sodium chloride


Outcome Measures

Primary Outcome Measures :
  1. Incidence of contrast-induced acute kidney injury [ Time Frame: 2 days ]
    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 :
  1. adverse clinical events [ Time Frame: 1 month ]
    adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742130


Locations
Italy
Ospedale Misericordia e Dolce
Prato, Italy, 59100
Sponsors and Collaborators
Ospedale Misericordia e Dolce
More Information

Responsible Party: Mauro Maioli, Medical Doctor, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT01742130     History of Changes
Other Study ID Numbers: Prato0705
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013

Keywords provided by Mauro Maioli, Ospedale Misericordia e Dolce:
Contrast-induced nephropathy
Contrast media
Angiography
Coronary percutaneous intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Kidney Injury
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases