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临床试验/NCT03288051
NCT03288051已完成不适用

Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Microcirculation in Free Flap Reconstruction of Intraoral Tumours.

Szeged University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年4月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.

研究概览

简要总结

Maintaining satisfactory tissue perfusion is an essential of success during reconstructive free flap surgery following malign oral cavity tumours. Intra- and postoperative goal-directed fluid therapy is an appropriate tool for that. Continuous cardiac output monitoring based fluid loading (complemented with vasopressor and/or inotropes if necessary) might be superior to conventional, central venous and arterial pressure monitoring in terms of morbidity, complications, optimal fluid balance and days spent in hospital. However, there is no data describing the effects of goal-directed fluid therapy (crystalloid or colloid) on microcirculation of free flaps implanted in the oral cavity during the post-operative period. The aim of this study is to observe the effects of continuous macrohaemodynamic monitoring based, goal-directed fluid therapy on microcirculation of forearm flaps during the perioperative period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Age over 18
  • Tumour location: intraoral
  • Free flap type: radial forearm
  • Signed informed concent form

排除标准

  • Vulnerable subject as defined in International Standards Organization 14155:2011
  • End stage oral cancer

研究组 & 干预措施

Colloid group

Active Comparator

干预措施: Norepinephrine (Drug)

Crystalloid group

Active Comparator

干预措施: Fluid management (Other)

Crystalloid group

Active Comparator

干预措施: Norepinephrine (Drug)

Crystalloid group

Active Comparator

干预措施: Dobutamine (Drug)

Colloid group

Active Comparator

干预措施: Fluid management (Other)

Colloid group

Active Comparator

干预措施: Dobutamine (Drug)

结局指标

主要结局

Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.

时间窗: 24 hours

Mean arterial pressure during the operation and the post-operative 24 hours.

时间窗: 24 hours

Assesment of free falp microcirculation by laser dopler flowmetry method.

时间窗: 24 hours

Changes of Cardiac Index during the operation and the post-operative 24 hours.

时间窗: 24 hours

Changes of Pulse pressure variation during the operation and the post-operative 24 hours

时间窗: 24 hours

次要结局

  • Length of Intensive Care Unit stay(24 hours)
  • Number of surgical or non-surgical complications.(24 hours)
  • Length of Hospital stay(10 days)

研究者

发起方
Szeged University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zsolt Molnár, MD, PhD, DEAA

head of department

Szeged University

研究点 (1)

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