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| Name | Class |
|---|---|
| Tehran Heart Center | OTHER |
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Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients undergoing diagnostic or interventional procedures requiring radiographic contrast agents. Recent studies have shown benefit in administering Sodium Bicarbonate over normal saline( the uniformly accepted prophylaxy) in preventing RCIN.Therefore the aim of the study is to evaluate the efficacy of sodium bicarbonate solved in normal saline compared with infusion of normal saline in prevention of RCIN.
Radio Contrast Induced Nephropathy (RCIN) remains a well recognized complication in patients undergoing diagnostic or interventional procedures requiring radiographic contrast agents and is the third leading cause of acquired acute renal failure in hospitalized patients. Strategies for the prevention of radiocontrast nephropathy have focused on countering vasoconstriction (pre-hydration, fenoldopam, and theophylline), enhancing flow through the nephron (diuretics), or protection against oxygen-free-radical injury (urinary alkalinization and N-acetylcysteine).
Among all prophylactic measures that have been proposed, adequate preprocedural and postprocedural hydration has demonstrated effectiveness in the prevention of radiocontrast nephropathy. Thus, it remains the most frequently applied measure in clinical practice.
A Recent study in May 2004 have shown benefit in administering Sodium Bicarbonate over normal saline as a prophylaxy.Since alkalizing renal tubular fluid with bicarbonate may reduce injury.
Comparisons: IV 154 mEq/L solution of NaCl 0.9% OR IV 154 mEq/ L sodium bicarbonate solved in 154 mEq/ L NaCl 0.9%. Each fluid is infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 1075 cc of 154 mEq/L solution of NaCl 0.9% , prepared by adding 75 cc of 154 mEq/L NaCl 0.9 % to 1000 cc of 154 mEq/L NaCl 0.9% |
|
| 2 | Active Comparator | 1075 cc fluid made by adding 75 cc of sodium bicarbonate 8.4% to 1000 cc of 154 mEq/ L NaCl 0.9%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Bicarbonate plus normal saline 0.9% | Drug | IV sodium bicarbonate 8.4% solved in 154 mEq/ L NaCl 0.9% (infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg. |
| Measure | Description | Time Frame |
|---|---|---|
| development of contrast induced nephropathy defined as an absolute (> or = 0.5 mg/dl) or relative increase (> or = 25%) in serum creatinine at 48 hours after exposure to a contrast agent compared to baseline serum creatinine values. | at 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| development of contrast induced nephropathy defined as an absolute (> or = 0.5 mg/dl) or relative increase (> or = 25%) in serum creatinine at 5 days after exposure to a contrast agent compared to baseline serum creatinine values. | at day 5 | |
| Days in hospital within the month post contrast |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Vasheghani-Farahani, M.D. | Tehran University of Medical Sciences, Tehran Heart Center | Study Director |
| Ebrahim Kassaian, M.D. | Tehran Heart Center | Principal Investigator |
| Akbar Fotuhi, M.D. | Tehran Heart Center | Principal Investigator |
| Mohammad Reza Khatami, M.D. | Tehran Heart Center | Principal Investigator |
| Mojtaba Salarifar, M.D. | Tehran Heart Center | Principal Investigator |
| Ahmad Iaminisharif, M.D. | Tehran Heart Center | Principal Investigator |
| Saeid Sadeghian, M.D. | Tehran Heart Center | Principal Investigator |
| Gholamreza Davoodi, M.D. | Tehran Heart Center | Principal Investigator |
| Alireza Amirzadegan, M.D. | Tehran Heart Center | Principal Investigator |
| Sirus Darabian, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran Heart Center | Tehran | 1411713138 | Iran |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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|
| normal saline 0.9% | Drug | IV 154 mEq/L solution of NaCl 0.9% (infused at the rate of 3 ml/kg/ hour one hour before the angiographic procedure, continuing at the rate of 1 ml/kg/ hour for 6 hours after the procedure. Maximum rate of fluid permitted is that for a body weight of 110 Kg.) |
|
| whithin the month post contrast |
| Urine PH after initial bolus | whithin 6 hours after initial bolus |
| development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at 48 hours. | at 48 hours |
| development of contrast induced nephropathy defined as at least 25% decrease in glomerular filtration rate (GFR) at day 5. | at day 5 |
| Tehran Heart Center |
| Principal Investigator |
| Gelareh Sadigh, M.D. | Tehran University of Medical Sciences | Principal Investigator |
| Amir Hossein Razavi, M.D. | Tehran University of Medical Sciences | Principal Investigator |
| Mohammad Ali Mansournia, MD | Tehran University of Medical Sciences | Principal Investigator |
| Mohammad Ali Boroumand, MD | Tehran Heart Center | Principal Investigator |
| Farah Aiatollahzade Esfehani, BSc,RN | Tehran Heart Center | Principal Investigator |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |