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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.But most studies have excluded patients with history of pulmonary edema, severe heart failure(NYHA 3-4), uncontrolled hypertension or ejection fraction less than 30%. Therefore the aim of this study is to evaluate the efficacy of sodium bicarbonate solved in half saline compared with infusion of half saline in prevention of RCIN in these groups of patients.
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 .
Most studies have excluded patients with history of pulmonary edema, severe heart failure(NYHA 3-4), uncontrolled hypertension or ejection fraction less than 30% and no specific protocol is tested for this group of patients. This study focuses on preventing RCIN in this specific group of patients .
Comparisons:1075 cc NaCl 0.45% or 75 cc of sodium bicarbonate 8.4% solved in one liter of NaCl 0.45%. 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 77 mEq/L solution of NaCl 0.45% , prepared by adding 75 cc of 77 mEq/L NaCl 0.45 % to 1000 cc of 77 mEq/L NaCl 0.45% |
|
| 2 | Active Comparator | 1075 cc fluid made by adding 75 cc of sodium bicarbonate solution 8.4% to 1000 cc of NaCl 0.45%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Bicarbonate | Drug | IV solution of NaCl 0.45% (Arm 1) or IV 75 cc of sodium bicarbonate 8.4% solved in 1 liter of NaCl 0.45% (Arm 2) . 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. |
| 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 |
|---|---|---|
| an absolute (> or = 0.5 mg/dl) or relative increase(> or= 25% ) in serum creatinine at day 5 after exposure to a contrast agent. | at day 5 | |
| Urine PH after initial bolus | within 6 hours after initial bolus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Farahani Vasheghani, 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 |
| Ebrahim Nematipur, 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 |
| Ali mohammad Hajzeinali, M.D. | Tehran Heart Center | Principal Investigator |
| Mohammad Alidoosti, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran Heart Center | Tehran | Iran |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR) at 48 hours. | at 48 hours |
| development of contrast induced nephropathy defined as 25% decrease in glomerular filtration rate (GFR)on day 5 . | on day 5 post contrast |
| Tehran Heart Center |
| Principal Investigator |
| Hamidreza Purhosseini,, M.D. | Tehran Heart Center | Principal Investigator |
| Ali Kazemisaeid, 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 |
| Abbas Soleimani, M.D. | Tehran Heart Center | Principal Investigator |
| Sirus Darabian, M.D. | Tehran Heart Center | Principal Investigator |
| Kianush Hossein, M.D. | 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 |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |