Phase 4 Study of Dexmedetomidine Effects on Preventing Contrast Induced Nephropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin
研究概览
简要总结
The aim of this study was to evaluate the effects of dexmedetomidine on renal function, hormonal and hemodynamic parameters in contrast media induced diabetic patients.
详细描述
Contrast nephropathy may occur after using intravenous contrast media and may result in acute renal failure. Contrast nephropathy usually reversible but in some cases it can be permanent. This situation increase the time of hospitalization and mortality of the patients. Although the only proved prevention from contrast nephropathy method is hydration, infusion of dexmedetomidine may keep the renal functions.
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
- •Scheduled for percutaneous coronary angiography
- •Diabetic patients
- •Creatinin value < 3 mg/dl
排除标准
- •Contrast agent hypersensitivity
- •Pregnant patients
- •Creatinin value ≥3mg/dl
- •patients have acute renal failure
研究组 & 干预措施
Control
Before the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours.
During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered.
100 ml/10min 0.9 % NaCl administered intravenously just before the angiography.
1 ml/kg/h 0.9 % sodium chloride administered intravenously during the procedure and was continued 1 hour after the angiography.
干预措施: 0.9 % NaCl (Drug)
Dexmedetomidine
Before the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours.
During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered.
Dexmedetomidine was diluted as 1 μg/ml. 1 μg/kg/10min dexmedetomidine administered intravenously just before the angiography.
1 μg/kg/h dexmedetomidine administered intravenously during the procedure and was continued 1 hour after the angiography.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
Before the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours.
During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered.
Dexmedetomidine was diluted as 1 μg/ml. 1 μg/kg/10min dexmedetomidine administered intravenously just before the angiography.
1 μg/kg/h dexmedetomidine administered intravenously during the procedure and was continued 1 hour after the angiography.
干预措施: 0.9 % NaCl (Drug)
结局指标
主要结局
Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin
时间窗: 1 day (from start of angioplasty till discharge from the hospital)
次要结局
- blood pressure(1 day (from start of angiography till discharge from the hospital))
- Heart rate(1 day (from start of angiography till discharge from the hospital))
- Blood electrolyte levels ( sodium, potassium, chloride)(before the angiography and just before the discharge from hospital)
- complete blood count(before the angiography and just before the discharge from hospital)
研究者
Aynur Akın
Prof Dr
TC Erciyes University