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

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ClinicalTrials.gov Identifier: NCT00639912
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : November 30, 2010
Sponsor:
Collaborator:
Azienda Sanitaria Ospedaliera
Information provided by:
Arcispedale Santa Maria Nuova-IRCCS

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contrast Induced Nephropathy Drug: sodium chloride Drug: sodium bicarbonate Phase 4

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 599 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2007
Primary Completion Date : May 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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% .
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.
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% .
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.
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.
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.
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.



Primary Outcome Measures :
  1. contrast induced nephropathy incidence [ Time Frame: 24, 48 and 72 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00639912


Locations
Italy
Azienda Ospedaliera Universitaria S. Anna
Ferrara, Emilia-romagna, Italy
Nuovo Ospedale Civile di Baggiovara
Modena, Emilia-Romagna, Italy, 41100
Arcispedale S. Maria Nuova
Reggio Emilia, Emilia-Romagna, Italy, 42100
Dipartimento di Cardiologia, Ospedale di Lavagna
Lavagna, Genova, Italy, 16033
Dipartimento di Cardiologia, Ospedale Maggiore
Parma, Italy, 43100
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Azienda Sanitaria Ospedaliera
Investigators
Principal Investigator: Antonio Manari, MD Arcispedale S. Maria Nuova Reggio Emilia

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manari Antonio, Arcispedale S. Maria Nuova
ClinicalTrials.gov Identifier: NCT00639912     History of Changes
Other Study ID Numbers: MAN1374
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: March 2008

Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
contrast induced nephropathy STEMI PCI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Kidney Diseases
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Urologic Diseases
Pharmaceutical Solutions