Comparing Sodium Bicarbonate Plus Isotonic Normal Saline Versus Isotonic Normal Saline Alone to Prevent Contrast-Induced Nephropathy in Patients Undergoing Coronary Angiography: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals aged 18 years or older with stable serum creatinine levels of at least 1.5 mg/dl , who were scheduled to undergo diagnostic or therapeutic coronary artery angiography during the next 24 hours of hospitalization and were available until 5 days after the procedure for serum creatinine measurements.
排除标准
- •serum creatinine levels of more than 8 mg/dl
- •previous history of dialysis
- •eGFR < 20
- •emergency catheterization
- •recent exposure to radiographic contrast agents (within previous two days of the study)
- •radiocontrast agent dosage needed more than 300 cc during the procedure
- •allergy to radiocontrast agent
- •pregnancy
- •administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study
- •need for continuous hydration therapy (e.g. sepsis )
- •history of Multiple myeloma , Pulmonary edema , Uncontrolled hypertension (treated systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than 100mmHg.) ,Severe heart failure (EF < 30% or NYHA 3-4).
研究组 & 干预措施
1
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%
干预措施: normal saline 0.9% (Drug)
2
1075 cc fluid made by adding 75 cc of sodium bicarbonate 8.4% to 1000 cc of 154 mEq/ L NaCl 0.9%.
干预措施: Sodium Bicarbonate plus normal saline 0.9% (Drug)
结局指标
主要结局
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.
时间窗: at 48 hours
次要结局
- 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(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)