Oral Hydration and Alkalinization is Non-Inferior to Intravenous Therapy for Prevention of Contrast Induced Nephropathy in Patients With Chronic Kidney Disease.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Contrast Induced Nephropathy
研究概览
简要总结
The increased risk for contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) undergoing coronary angiography (CAG) has been established. Current and historical data on CIN prevention strategies have shown wide variation with respect to the optimal type, route and timing of these therapies. We investigate the role for oral hydration and/or oral sodium bicarbonate administration compared to intravenous hydration and/or sodium bicarbonate in patients with CKD undergoing CAG.
详细描述
This is a single center study randomizing patients with CKD undergoing CAG into 4 groups: 1) Intravenous normal saline, 2) Intravenous normal saline and intravenous bicarbonate, 3) oral hydration, and 4) oral hydration and oral bicarbonate. The primary endpoint was the occurrence of contrast-medium-induced nephropathy defined as greater than 25% increase in serum creatinine from baseline or an absolute increase of 0.5 mg/dL from baseline at 72 hours following exposure to radiocontrast. Secondary endpoints include the length of hospitalization and in-house mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable serum creatinine levels of at least 1.1 mg/dL or estimated creatinine clearance less than 60 mL/min
- •Scheduled for diagnostic, elective cardiac angiography
排除标准
- •Serum creatinine levels >8.0 mg/dL
- •Change in serum creatinine levels of at least 0.5 mg/dL during the previous 24 hours
- •Preexisting dialysis
- •Multiple myeloma or other myeloproliferative disease
- •Current CHF or recent history of flash pulmonary edema
- •Current myocardial infarction
- •Symptomatic hypokalemia
- •Uncontrolled hypertension (treated systolic blood pressure >200 mmHg or diastolic blood pressure >100mmHg)
- •Exposure to radiocontrast within 7 days the study
- •Emergency Catheterization
- •Allergy to radiographic contrast
- •Administration of dopamine, mannitol, fenoldapam, or N-acetylcysteine during the time of the study
- •Severe COPD
- •Serum Bicarb > 28
- •Sodium <133
研究组 & 干预措施
Intravenous Hydration
Pretreatment with a 3 mL/kg bolus of intravenous normal saline solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1ml/kg per for 6 hours after the procedure.
干预措施: Intravenous Hydration (Other)
Intravenous hydration and sodium bicarbonate
Pretreatment with a 3 mL/kg bolus of intravenous sodium bicarbonate solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1 mL/kg for 6 hours after the procedure.
干预措施: Intravenous Hydration (Other)
Intravenous hydration and sodium bicarbonate
Pretreatment with a 3 mL/kg bolus of intravenous sodium bicarbonate solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1 mL/kg for 6 hours after the procedure.
干预措施: Intravenous sodium bicarbonate (Drug)
Oral hydration
Oral hydration with 500 mL of water to be started 4 hours prior to contrast exposure and stopped 2 hours prior to procedure followed by oral hydration with 600 mL of water post procedure
干预措施: Oral hydration (Other)
Oral hydration and oral sodium bicarbonate
Oral hydration with 500 mL of water to be started 4 hours prior to procedure and stopped 2 hours prior to contrast exposure, with the addition of 3.9 grams (46.4 mEq) of oral sodium bicarbonate to be given 20 minutes prior to contrast exposure followed by 1.95 grams (30.4 mEq) of oral sodium bicarbonate 2 hours and 4 hours after the initial dose
干预措施: Oral hydration (Other)
Oral hydration and oral sodium bicarbonate
Oral hydration with 500 mL of water to be started 4 hours prior to procedure and stopped 2 hours prior to contrast exposure, with the addition of 3.9 grams (46.4 mEq) of oral sodium bicarbonate to be given 20 minutes prior to contrast exposure followed by 1.95 grams (30.4 mEq) of oral sodium bicarbonate 2 hours and 4 hours after the initial dose
干预措施: Oral sodium bicarbonate (Drug)
结局指标
主要结局
Contrast Induced Nephropathy
时间窗: 72 hours
Defined as greater than 25% increase in serum creatinine from baseline or an absolute increase of 0.5 mg/dL from baseline at 72 hours.
次要结局
- Aspiration(72 hours)
- Hypotension(72 hours)
- Length of Hospital Stay(72 hours)
- In-Hospital Mortality(72 hours)