Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 5
- 主要终点
- Development of contrast-induced nephropathy, CIN, defined as an increase in serum creatinine of 25% or more from pre-intervention baseline to within 48-72 hours after administration of the radiographic contrast.
研究概览
简要总结
Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.
详细描述
A decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. Deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy. However, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear.
It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels. A recent trial found a lower frequency of creatinine rise > 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws.
Comparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1 ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2 ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging.
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
- None
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
- •Booked for cardiac or other non-renal arteriography
- •Pre-existing reduced kidney function: Serum Creatinine >= 1.3 & <= 4 mg/dl (female gender) or >= 1.5 & <= 5 mg/dl (male gender)
- •Age > 18 years
排除标准
- •GFR MDRD estimate < 15 ml/min/m2
- •End-stage renal disease already on dialysis
- •Known current Acute Kidney Failure with serum creatinine rise of > 0.5 mg/dl within 24 hours
- •Pulmonary edema - current or within 48 hours
- •Clinically relevant ascites, edema or other fluid overload
- •Uncontrolled hypertension (> 165 mmHg systolic, or > 105 mmHg diastolic)
- •Hemodynamically unstable patient requiring IV nitroglycerine, or IV fluid or inotropes for blood pressure support
- •Emergency (unplanned) angiography
- •IV contrast procedure
- •Exposure to iodinated radiocontrast within 3 days prior to study
- •Prior anaphylactoid reaction to contrast
- •Planned administration of N-acetylcysteine
- •Planned administration of dopamine, fenoldopam or mannitol
- •Current pregnancy
研究组 & 干预措施
Bicarbonate
Bicarbonate solution infusion
干预措施: 1/6 M (166 mEq/L) IV Sodium Bicarbonate (Drug)
Saline
Standard volume expansion
干预措施: 0.9% (154 mEq/L) IV Sodium Chloride (Drug)
结局指标
主要结局
Development of contrast-induced nephropathy, CIN, defined as an increase in serum creatinine of 25% or more from pre-intervention baseline to within 48-72 hours after administration of the radiographic contrast.
时间窗: 48-72 hours
次要结局
- Major adverse cardiovascular events(Two months)
- Death(Two months)
- Group mean change in serum creatinine(48-72 hours)
- Days in hospital within the week post contrast(One week)
- Requirement for dialysis(Two months)
- Atheroembolic events(Two months)