Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Successful clearance rate of sodium bicarbonate
研究概览
简要总结
This is a study looking at the use of sodium bicarbonate to restore the flow of blocked central line devices in patients with blood cancers.
Central line devices uses thin tubes that are placed into a vein in the body to give medicines, fluids, nutrients, blood products, etc.
Sometimes, the lines become blocked. The standard procedure to get the line working again is to use alteplase, a protein that dissolves blood clots. While blood clotting is one cause of a blocked line, other reasons included the formation of calcium deposits. Sodium bicarbonate is routinely used in the treatment of patients receiving chemotherapy. Sodium bicarbonate is a liquid drug which is capable of dissolving protein and calcium deposits.
This study will compare whether sodium bicarbonate works just as well as alteplase to recover the function of a blocked line.
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
- •Hematology patients with indwelling CVC/PICC line.
- •Patients continuing to receive chemotherapy treatment for consolidation, intensification and maintenance regimens in hematological malignancies such as in acute leukemia, lymphoma, myelodysplastic syndrome, supportive care measures using blood products, ongoing anti-infective treatments, and nutrition.
- •Patients whose CVC/PICC line becomes obstructed during routine care are being identified and presented to attending physician and pharmacist.
- •Mechanical obstruction having been ruled out by visual inspection and manipulation of the patient's posture or extremities or both.
排除标准
- •Patients with hemodialysis line occlusions
- •Anyone with documentation of prior history of alteplase allergy or hypersensitivity reactions
研究组 & 干预措施
Alteplase then Sodium Bicarbonate
Alteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be administered.
干预措施: Sodium Bicarbonate 8.4% Solution for Injection (Drug)
Alteplase then Sodium Bicarbonate
Alteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be administered.
干预措施: Alteplase Injectable Solution (Drug)
Sodium Bicarbonate then Alteplase
Sodium bicarbonate will first be administered to restore flow. If flow is not restored, then alteplase will be administered.
干预措施: Sodium Bicarbonate 8.4% Solution for Injection (Drug)
Sodium Bicarbonate then Alteplase
Sodium bicarbonate will first be administered to restore flow. If flow is not restored, then alteplase will be administered.
干预措施: Alteplase Injectable Solution (Drug)
结局指标
主要结局
Successful clearance rate of sodium bicarbonate
时间窗: 3 hours
Successful clearance rate of alteplase
时间窗: 3 hours
次要结局
未报告次要终点