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
  Purpose

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 Intervention Phase
Contrast Induced Acute Kidney Injury
Drug: sodium bicarbonate solution
Drug: Isotonic saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Ospedale Misericordia e Dolce:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 300
Study Start Date: January 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742130

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

No publications provided

Responsible Party: Mauro Maioli, Medical Doctor, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT01742130     History of Changes
Other Study ID Numbers: Prato0705
Study First Received: December 2, 2012
Last Updated: November 5, 2013
Health Authority: Italy: National Bioethics Committee

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

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

ClinicalTrials.gov processed this record on July 22, 2014