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Effects of Hydration to Prevent Contrast Induced Nephropathy in PCI for ST-elevation Myocardial Infarction. (CINIMA)

This study has been completed.
Sponsor:
Collaborator:
Azienda Sanitaria Ospedaliera
Information provided by:
Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier:
NCT00639912
First received: March 14, 2008
Last updated: November 29, 2010
Last verified: March 2008

March 14, 2008
November 29, 2010
June 2007
May 2010   (final data collection date for primary outcome measure)
contrast induced nephropathy incidence [ Time Frame: 24, 48 and 72 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00639912 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Effects of Hydration to Prevent Contrast Induced Nephropathy in PCI for ST-elevation Myocardial Infarction.
Randomized Trial on the Effects of Hydration With Sodium Chloride Versus Sodium Bicarbonate to Prevent Contrast Induced Nephropathy, in Patients Undergoing Primary Coronary Interventions for Acute ST Elevation Myocardial Infarction.

The aim of the study is to test the efficacy of low versus high volume hydration and two different solutions (sodium chloride versus sodium bicarbonate) in preventing contrast induced nephropathy (CIN) in ST elevation myocardial infarction (STEMI) patients undergoing primary PCI.

Contrast-induced nephropathy (CIN) is associated with increased morbidity and mortality after percutaneous coronary interventions (PCI). Patients with ST elevation myocardial infarction (STEMI) are at high risk for CIN because of hemodynamic instability of the patient, inability to prevent the phenomenon (hydration) and the possible exposure to high volume of contrast media. Recent reports have shown incidence of CIN up to 19% in this population and a related increase of in-hospital mortality.

Merten e coll. (JAMA 2004) reported that sodium bicarbonate infusion before and after contrast exposure in patients with chronic renal failure and without myocardial infarction (AMI) is more effective than sodium chloride in preventing CIN.

Up to date there is no evidence of any effective prophylactic measures in patients with STEMI undergoing primary PCI.

The aim of the study is to test the efficacy of low versus high volume hydration and the efficacy of two different solutions (sodium chloride versus sodium bicarbonate) in preventing CIN in STEMI patients undergoing primary PCI.

The infusion of the randomized solution will start just after randomization and after determination of baseline serum creatinine.

Determination of serum creatinine will be repeated at 24, 48 and 72 hours after randomization. Creatinine clearance will be calculated with Cockroft-Gault formula and MDRD.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Contrast Induced Nephropathy
  • Drug: sodium chloride
    Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/Kg/hour for 12 hours.
    Other Name: Normal saline. Isotonic saline. Sodium chloride 0.9% .
  • Drug: sodium chloride
    Solution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours
    Other Name: Normal saline. Isotonic saline. Sodium Chloride 0.9% .
  • Drug: sodium bicarbonate
    154 mEq/L of sodium bicarbonate in dextrose solution. Rate of infusion: 1 ml/Kg/hour for 12 hours.
    Other Name: Addition of 77 ml 8,4% Na bicarbonate to 423 ml 5% dextrose.
  • Drug: sodium bicarbonate
    154 mEq/L of sodium chloride in dextrose solution. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours.
    Other Name: Addition of 77 ml 8,4% Na bicarbonate to 423 ml 5% dextrose.
  • Active Comparator: A: low volume saline
    Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/kg/hour for 12 hours after the procedure, starting in the Cath Lab.
    Intervention: Drug: sodium chloride
  • Active Comparator: B: high volume saline
    Solution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath lab.
    Intervention: Drug: sodium chloride
  • Active Comparator: C: low volume sodium bicarbonate
    Solution of 154 mEq/L of sodium bicarbonate. Rate of infusion: 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath Lab.
    Intervention: Drug: sodium bicarbonate
  • Active Comparator: D: high volume sodium bicarbonate
    Solution of 154 mEq/L of sodium bicarbonate. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath Lab.
    Intervention: Drug: sodium bicarbonate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
599
October 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years of years
  • Chest pain lasting at least 30 minutes, non responsive to nitrates, associated to ST elevation of at least 0.2 mV on surface ECG in two or more contiguous leads or to new left bundle branch block.
  • Informed consent

Exclusion Criteria:

  • Chronic hemodialytic or peritoneal treatment
  • Coronary anatomy unsuitable for PCI
  • Need of emergency coronary artery by-pass grafting
  • Post-anoxic coma
  • Pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00639912
MAN1374
No
Manari Antonio, Arcispedale S. Maria Nuova
Arcispedale Santa Maria Nuova-IRCCS
Azienda Sanitaria Ospedaliera
Principal Investigator: Antonio Manari, MD Arcispedale S. Maria Nuova Reggio Emilia
Arcispedale Santa Maria Nuova-IRCCS
March 2008

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