Early Hydration in Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:
NCT01742130
First received: December 2, 2012
Last updated: November 5, 2013
Last verified: November 2013

December 2, 2012
November 5, 2013
January 2011
October 2013   (final data collection date for primary outcome measure)
Incidence of contrast-induced acute kidney injury [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01742130 on ClinicalTrials.gov Archive Site
adverse clinical events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration
Same as current
Not Provided
Not Provided
 
Early Hydration in Acute Myocardial Infarction
Early Hydration in Acute Myocardial Infarction: Sodium Bicarbonate Versus Saline for the Prevention on Contrast-induced Acute Kidney Injury

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Contrast Induced Acute Kidney Injury
  • Drug: sodium bicarbonate solution
    Other Name: 154 mEq/L in dextrose and H2O
  • Drug: Isotonic saline
    Other Name: 0.9% sodium chloride
  • 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
    Intervention: Drug: sodium bicarbonate solution
  • 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
    Intervention: Drug: Isotonic saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01742130
Prato0705
Yes
Mauro Maioli, Ospedale Misericordia e Dolce
Ospedale Misericordia e Dolce
Not Provided
Not Provided
Ospedale Misericordia e Dolce
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP