NCT03073304已完成不适用
A Randomized Controlled Study With the Aim to Compare Crystalloid Prime Solution With a Prime Solution Containing Packed Red Blood Cells in Relation to the Patient's Regional Metabolic Needs and Immunological Influence During Isolated Limb Perfusion
Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年2月24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
- 18
- 试验地点
- 1
- 主要终点
- Lactate level during and after perfusion.
研究概览
简要总结
The primary aim of this study is to investigate the possibility to replace an erythrocyte based prime solution with a crystalloid based prime solution while maintaining metabolic function. Secondary also to study if potentially reduced immunological influence is obtained during hyper thermic isolated limb perfusion with a crystalloid based prime solution.
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
- None
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
- •The patient scheduled for treatment with isolated hyperthermic perfusion
- •Age over 18 years.
- •Signed informed consent
排除标准
- 未提供
研究组 & 干预措施
Control
Active Comparator
Erythrocyte based prime solution
干预措施: Erythrocyte based prime solution (Drug)
Intervention
Experimental
Crystalloid based prime solution
干预措施: Crystalloid based prime solution (Drug)
结局指标
主要结局
Lactate level during and after perfusion.
时间窗: 1 hour
Lactate level during and after perfusion.
次要结局
- Complications(30 days)
- Oxygen extraction during, and after perfusion.(1 hour)
- Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.(1 hour)
- Hematocrit during and after completion of perfusion.(1 hour)
- Immunological effects(30 days)
研究者
Roger Olofsson Bagge
Associate professor
Sahlgrenska University Hospital, Sweden
研究点 (1)
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