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| Name | Class |
|---|---|
| Azienda Sanitaria Ospedaliera | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: low volume saline | Active Comparator | 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. |
|
| B: high volume saline | Active Comparator | 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. |
|
| C: low volume sodium bicarbonate | Active Comparator | 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. |
|
| D: high volume sodium bicarbonate | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium chloride | Drug | Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/Kg/hour for 12 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| contrast induced nephropathy incidence | 24, 48 and 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Manari, MD | Arcispedale S. Maria Nuova Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria S. Anna | Ferrara | Emilia-Romagna | Italy | |||
| Nuovo Ospedale Civile di Baggiovara |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16949378 | Result | 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. doi: 10.1016/j.amjcard.2006.01.022. Epub 2006 Feb 23. | |
| 15519007 | Result | 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. doi: 10.1016/j.jacc.2004.07.043. |
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| sodium chloride | Drug | 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 |
|
|
| sodium bicarbonate | Drug | 154 mEq/L of sodium bicarbonate in dextrose solution. Rate of infusion: 1 ml/Kg/hour for 12 hours. |
|
|
| sodium bicarbonate | Drug | 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. |
|
|
| Modena |
| Emilia-Romagna |
| 41100 |
| Italy |
| Arcispedale S. Maria Nuova | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Dipartimento di Cardiologia, Ospedale di Lavagna | Lavagna | Genova | 16033 | Italy |
| Dipartimento di Cardiologia, Ospedale Maggiore | Parma | Parma | 43100 | Italy |
| 16807414 | Result | 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. doi: 10.1056/NEJMoa054209. |
| 15150204 | Result | 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. doi: 10.1001/jama.291.19.2328. |
| 24500238 | Derived | Manari A, Magnavacchi P, Puggioni E, Vignali L, Fiaccadori E, Menozzi M, Tondi S, Robotti S, Ferrari D, Valgimigli M. Acute kidney injury after primary angioplasty: effect of different hydration treatments. J Cardiovasc Med (Hagerstown). 2014 Jan;15(1):60-7. doi: 10.2459/JCM.0b013e3283641bb8. |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D017693 | Sodium Bicarbonate |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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