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临床试验/NCT02449317
NCT02449317已完成不适用

Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast

Mahidol University0 个研究点目标入组 56 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
主要终点
serum creatinine at 48-72 hours after contrast administration

研究概览

简要总结

Bioelectrical impedance analysis guided volume expansion for the prevention of contrast induced-acute kidney injury

详细描述

Compared bioelectrical impedance analysis guided hydration therapy versus standard hydration for the prevention of contrast induced-acute kidney injury

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 (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-90 yr
  • •Chronic kidney disease stage 3 & 4 (eGFR 15-60 ml/min/m2)
  • •elective cardiac catheterization

排除标准

  • •Contrast media administration in the past 14 days
  • •congestive heart failure (NYHA III-IV, ascites , pleuropericardial effusion ,severe valvular heart disease
  • •Kidney transplant status or RRT
  • •Emergency cardiac catheterization
  • •Allergy to radiographic contrast media
  • •Unstable renal function (change in serum creatinine ≥ 0.5 mg/dl or 25% within 14 days prior to the study
  • •Not inform consent
  • •left ventricular ejection fraction < 40 %
  • •Liver cirrhosis child B or C
  • •Dosage of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker changed in past 2 wk

研究组 & 干预措施

Control

Other

standard hydration : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours

干预措施: standard hydration (Other)

Bioimpedance guided

Experimental

Bioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water

  • extracellular water/total body water < 0.36 : 4 ml/kg/hr
  • extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr
  • extracellular water/total body water > 0.4 : 1 ml/kg/hr

干预措施: Bioimpedance guided (Other)

结局指标

主要结局

serum creatinine at 48-72 hours after contrast administration

时间窗: 48-72 hr

Acute kidney injury

次要结局

  • serum creatinine at 2 weeks after contrast administration(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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