Determining the Safe Dosage of Ascorbic Acid Used in the Treatment of Occluded Totally Implanted Central Venous Catheter.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Restore patency
研究概览
简要总结
The hypothesis of the study is to evaluate whether ascorbic acid is able to clear totally implanted central venous catheter
详细描述
Totally implanted catheter is often occluded and thrombolytic drugs are usually used to restore permeability. In Brazil, the ascorbic acid has been used successfully by a service specialist in cancer treatment. However, no literature on international research that evaluates the efficacy and safety of this procedure. That was why it was decided to develop this research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of partial or complete obstruction of the totally implanted central venous catheter;
- •No signs of inflammation in the area of the port.
排除标准
- •Use of oral anticoagulants or intravenous administration in the last seven days;
- •Diagnostic and / or suspected infection in the totally implanted central venous catheter;
- •Rupture, displacement or fissure of the totally implanted central venous catheter;
- •Presence of thrombosis in the vein where the catheter is inserted.
研究组 & 干预措施
group 50 mg ascorbic acid
this arm received a dose of 50 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes
干预措施: Ascorbic Acid (Drug)
group 100mg ascorbic acid
this arm received a dose of 100 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes
干预措施: Ascorbic Acid (Drug)
group 200mg ascorbic acid
this arm received a dose of 200 mg of ascorbic acid administered inside the catheter and maintained for up to 60 minutes
干预措施: Ascorbic Acid (Drug)
结局指标
主要结局
Restore patency
时间窗: 60 minutes after administration of ascorbic acid
the ascorbic acid is administered and remains inside the catheter within 60 minutes. The recovery of permeability is checked every 15 minutes until the maximum of 60 minutes
次要结局
- Eosinophil count(within 24 hours)