Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast
研究概览
简要总结
Deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures. The purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition.
We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.
详细描述
We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.
Phase 2/3 study Study Type: Interventional Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study.
Subjects: Consecutive samples of all inpatients who meet the inclusion criteria
Primary outcomes: Development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast.
Secondary outcomes: change in serum bicarbonate; change in serum potassium; change in serum creatinine.
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
- Single
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
- •18+ years of age
- •Inpatient at Hospital Universitario San Vicente de Paúl scheduled to undergo diagnostic CT scan using contrast or angiography and either
- •Serum creatinine 1.2 mg/dl or more, or
- •Type 2 Diabetes Mellitus
排除标准
- •Current clinical diagnosis of exacerbated congestive heart failure
- •Exposure to contrast 30 days prior to study
- •Allergy to contrast dye
- •Chronic renal disease with dialysis therapy
- •Acute renal failure with dialytic urgency
- •Urgency procedure needed
- •Systolic blood pressure < 90 or vasopressor support
- •No authorization by patient or physician in charge
- •Serum potassium < 3 mEq/L
- •Ejection fraction < 35% by previous echocardiography
- •Acute pulmonary edema in previous 48 hours
结局指标
主要结局
development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast
时间窗: 48 h
次要结局
- change in serum bicarbonate; change in serum potassium; change in serum creatinine(48 h)