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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 University1 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1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
22
试验地点
1
主要终点
cardiac index

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

研究组 & 干预措施

Acetate-free solution first

Experimental

Acetate-free solution first : hemodialysis 4 hours with Acetate-free solution (Acetate 0 mEq/L Citrate 2 mEq/L) at the first session after enrollment, and then switch to Acetate-based solution (Acetate 3 mEq/L Citrate 0 mEq/L) at the next 4-hr hemodialysis session

干预措施: Acetate-free dialysis solution (Biological)

Acetate-based solution first

Active Comparator

Acetate-based solution first : hemodialysis 4 hours with Acetate-based solution (Acetate 3 mEq/L Citrate 0 mEq/L) at the first session after enrollment, and then switch to Acetate-free solution (Acetate 2 mEq/L Citrate 2 mEq/L) at the next 4-hr hemodialysis session

干预措施: Acetate-free dialysis solution (Biological)

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 (1)

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