Randomized Trial on the Effects of Hydration to Prevent Contrast Induced Nephropathy in Percutaneous Coronary Intervention (PCI) for Segment Elevation Myocardial Infarction (STEMI) - Full Text View

Sponsors and Collaborators:	Arcispedale Santa Maria Nuova Azienda Sanitaria Ospedaliera
Information provided by:	Arcispedale Santa Maria Nuova
ClinicalTrials.gov Identifier:	NCT00639912

Purpose

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	Intervention	Phase
Contrast Induced Nephropathy	Drug: sodium chloride Drug: sodium bicarbonate	Phase IV

MedlinePlus related topics: Heart Attack

Drug Information available for: Sodium chloride Chlorides Sodium bicarbonate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Arcispedale Santa Maria Nuova:

Primary Outcome Measures:

contrast induced nephropathy incidence [ Time Frame: 24, 48 and 72 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	June 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Solution of 154 mEq/L of sodium chloride Rate of infusion: 1ml/Kg/hour for 12 hours, starting in the Cath Lab	Drug: sodium chloride Solution of 154 mEq/L of sodium chloride Rate of infusion: 1ml/Kg/hour for 12 hours
B: Active Comparator Solution of 154 mEq/L of sodium chloride Rate of infusion: 3ml/Kg for 1 hour, followed by 1ml/Kg/hour for 12 hours, starting in the Cath lab	Drug: sodium chloride Solution of 154 mEq/L of sodium chloride Rate of infusion: 3ml/Kg for 1 hour, followed by 1ml/Kg/hour for 12 hours
C: Active Comparator Solution of 154 mEq/L of sodium bicarbonate Rate of infusion: 1ml/Kg/hour for 12 hours, starting in the Cath Lab	Drug: sodium bicarbonate Solution of 154 mEq/L of sodium bicarbonate Rate of infusion: 1ml/Kg/hour for 12 hours
D: Active Comparator Solution of 154 mEq/L of sodium bicarbonate Rate of infusion: 3ml/Kg for 1 hour, followed by 1ml/Kg/hour for 12 hours, starting in the Cath Lab	Drug: sodium bicarbonate Solution of 154 mEq/L of sodium chloride Rate of infusion: 3ml/Kg for 1 hour, followed by 1ml/Kg/hour for 12 hours

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.

Mertan 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639912

Contacts

Contact: Antonio Manari, MD	00390522295846	manari.antonio@asmn.re.it
Contact: Gianluca Pignatelli, MD	00390522296595	pignatelli.gianluca@asmn.re.it

Locations

Italy, Emilia-Romagna
Azienda Ospedaliera Universitaria S. Anna	Recruiting
FERRARA, Emilia-Romagna, Italy
Contact: Gianfranco Percoco, MD
Principal Investigator: Gianfranco Percoco, MD
Arcispedale S. Maria Nuova	Recruiting
Reggio Emilia, Emilia-Romagna, Italy, 42100
Contact: Antonio Manari, MD 00390522295846 manari.antonio@asmn.re.it
Principal Investigator: Antonio Manari, MD
Azienda Ospedaliera Policlinico Baggiovara	Recruiting
Modena, Emilia-Romagna, Italy, 41100
Contact: Paolo Magnavacchi, MD 0039059437316 p.magnavacchi@ausl.mo.it
Principal Investigator: Paolo Magnavacchi, MD

Sponsors and Collaborators

Arcispedale Santa Maria Nuova

Azienda Sanitaria Ospedaliera

Investigators

Principal Investigator:

Antonio Manari, MD

Arcispedale S. Maria Nuova Reggio Emilia

More Information

Publications of Results:

McCullough PA, Adam A, Becker CR, Davidson C, Lameire N, Stacul F, Tumlin J; CIN Consensus Working Panel. Risk prediction of contrast-induced nephropathy. Am J Cardiol. 2006 Sep 18;98(6A):27K-36K. Epub 2006 Feb 23. Review.

Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5.

Marenzi G, Assanelli E, Marana I, Lauri G, Campodonico J, Grazi M, De Metrio M, Galli S, Fabbiocchi F, Montorsi P, Veglia F, Bartorelli AL. N-acetylcysteine and contrast-induced nephropathy in primary angioplasty. N Engl J Med. 2006 Jun 29;354(26):2773-82.

Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34.

Responsible Party:	Arcispedale S. Maria Nuova ( Manari Antonio )
Study ID Numbers:	MAN1374
Study First Received:	March 14, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00639912
Health Authority:	Italy: Ethics Committee

Keywords provided by Arcispedale Santa Maria Nuova:

contrast induced nephropathy STEMI PCI

Study placed in the following topic categories:

Necrosis
Heart Diseases
Urologic Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Kidney Diseases
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009