Non-inferiority of Clinical Trials in Comparison With the Length of Totally Implemented Porth-a-Cath Maintenance From 60 Versus 90 Days
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Incidence of catheter obstruction or catheter-related infection
研究概览
简要总结
Abstract: Antineoplastic therapy (AT) is one of the most used treatment modalities to fight cancer, either curatively or palliatively. There are several possible routes of administration, but the intravenous is the most used for its safe absorption and maintenance of the drug's serum level (1). Among the central catheters used in oncology, the long-term Totally Implantable (CTI) catheter is one of the most well accepted by patients and healthcare professionals. Being used in the administration of fluids, medication, parenteral nutrition or to obtain blood. Maintaining the CTI is essential to maintain its permeability, and thus, its proper functioning (2-4). The COVID-19 pandemic requires several readjustments from health institutions to ensure healthy environments for patients and less exposure to the hospital environment, one of the measures to focus on increasing the maintenance time of the ICU from 30 to 60 days. Objective: To verify the safety of increasing the maintenance interval of the Port-a-Cath catheter from 30 to 60 days through the rate of infection, obstruction, dysfunction in the infusion of solutions and blood reflux at the end of a year of follow-up. Method: This is an observational study, a single research arm, with a scheduled duration from January 2021 to August 2022 at the chemotherapy clinics of the A.C.Camargo Cancer Center. Expected results: This investigation is expected to demonstrate that maintenance with saline every 60 days does not increase obstruction or infection in patients who are in clinical follow-up compared to maintenance for 30 days.
详细描述
1.Patients and methods
1.1. Study design
Recruitment will take place during three months in the chemotherapy ambulatory at A.C. Camargo Cancer Center. Patients will be invited to participate in this study once they undergo maintenance of the fully implanted catheter (FIC), according to institutional routine. If the invited patient meets the inclusion and exclusion criteria defined in this study, he will respond to the financial assessment (Appendix 1). In the next step, he will be instructed to wait for the researcher to contact him to inform the next day of catheter maintenance.
After the clinical findings and randomization assessment, the patient will be informed to which group he belongs and he will be responsible for scheduling the next maintenance appointment, according to the group to which he belongs.
The study researcher will be responsible for checking if all participants have planned and carried out their maintenance according to his group. He will make sure that they underwent the catheter maintenance in the recommended time period. The study will consist of two arms, with the control group consisting of patients undergoing catheter care every 60 days as recommended in the current institutional protocol. The experimental group will consist of patients who will have a maintenance every 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Participants over 18 years old
- •Consent to participate by signing the consent form.
- •No intravenous antineoplastic therapy regimen schedule (clinical follow-up).
- •To have a functioning, fully implantable catheter with venous return, no resistance during solution infusion, no obstruction or evidence of infection at the time of recruitment.
排除标准
- •Use of any type of anticoagulant / antiplatelet drugs.
研究组 & 干预措施
A
Porth-a-Cath maintenance with 60-day interval
B
Porth-a-Cath maintenance with 90-day interval
干预措施: 90 days interval between catheter maintenance (Other)
结局指标
主要结局
Incidence of catheter obstruction or catheter-related infection
时间窗: 1 year
This evaluation will be performed using the power test with 80% , significance level of 5%, and a rate of 1.35% in obstruction in the control group based on a retrospective study (8) and 2.0% of obstruction in the experimental group with study margin of 2.5%
次要结局
- Financial toxicity(1 year)
