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临床试验/NCT01778283
NCT01778283已完成4 期

Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2012年10月最近更新:
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适应症

试验速览

阶段
4 期
状态
已完成
入组人数
22
试验地点
2
主要终点
cardiac index
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to detemine whether effect of Acetate-free solution on cardiac index and cardiac output measured by saline dilution techniques compares with Acetate-based solution in online-hemodiafiltration

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • •End-stage renal disease patients with age over 20 years and stable clinical status
  • •Dialytic age > 6 months
  • •Maintenance hemodialysis with online-hemodiafiltration mode at King Chulalongkorn Memorial Hospital
  • •Use arteriovenous fistula or arteriovenous graft as vascular access for hemodialysis
  • •No vascular access recirculation
  • •No liver impairment
  • •No severe, intractable metabolic acidosis or alkalosis (HCO3 <15, >30)
  • •No pre-existing severe, intractable hypocalcemia (Ca < 7.5) or clinical of hypocalcemia

排除标准

  • •On hemodialysis via tunnel catheter
  • •Vascular access recirculation
  • •Liver dysfunction
  • •Severe, intractable metabolic acidosis or alkalosis (HCO3 <15, >30)
  • •Pre-existing severe, intractable hypocalcemia (Ca < 7.5) or clinical of hypocalcemia
  • •Acute or recent myocardial ischemia or congestive heart failure (within 1 months)
  • •Threatening arrhythmia (VT, VF, sustained SVT, AF with rapid ventricular response)
  • •Patients affected by acute or chronic infections, malignant tumor

结局指标

主要结局

cardiac index

时间窗: 6 months

cardiac index and cardiac output was measured by ultrasound dilution technique

Cardiac output

时间窗: 6 months

cardiac index and cardiac output was measured by ultrasound dilution technique

次要结局

  • blood pressure(6 months)
  • peripheral vascular resistance(6 moths)
  • Patients' symptoms(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khajohn Tiranathanagul

Doctor

Chulalongkorn University

研究点 (2)

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