Does Bicarbonate in Addition to Theophylline Reduce Contrast Induced Nephropathy Compared to Sodium Chloride?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 主要终点
- Contrast induced nephropathy
研究概览
简要总结
Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is administered to the patients especially in patients with already existing renal impairment. Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium chloride alone. The combination of the two prophylaxis has not been investigated yet.
Aim of this prospective randomized trial is to investigate the effect of hydration with sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all patients receive.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Increased risk for contrast induced nephropathy defined as:
- •Serum creatinine level ≥ 1.1 mg/dl OR
- •Serum creatinine level ≥ 0.8 mg/dl plus an additional risk factor like diabetes mellitus, renal failure in past medical history or nephrotoxic medication (aminoglycoside, vancomycin, amphotericin B, diuretic)
排除标准
- •pre-existing renal replacement therapy
- •unstable serum creatinine levels (difference of more than ±0.4 mg/dl within 3 days before contrast application)
- •contraindications for theophylline or sodium bicarbonate (allergies, tachycardia, alkalosis, hypokalemia)
- •additional interventions that might influence renal function
研究组 & 干预措施
Bicarbonate and theophylline
Hydration with bicarbonate in addition to theophylline
干预措施: Hydration with bicarbonate in addition to theophylline (Other)
Sodium and theophylline
Hydration with sodium chloride in addition to theophylline
干预措施: Hydration with sodium chloride in addition to theophylline (Other)
结局指标
主要结局
Contrast induced nephropathy
时间窗: 48 hours
Raise in serum creatinine of ≥25% or ≥0.5 mg/dl
次要结局
- Change in urine pH(48 hours)
- Change in urine bicarbonate-concentration(48 hours)
- Change of serum creatinine levels over time(48 hours)
- Change of creatinine clearance over time(48 hours)
- Change in blood pH(48 hours)
- Change in blood bicarbonate-concentration(48 hours)
- Change in blood sodium-concentration(48 hours)
- Change in urine pH sodium-concentration(48 hours)
- Incidence of patients with need for dialysis(30 days)