Comparison of Safety, Efficacy, and Patient-perceived Satisfaction Between Initial Routine Peripherally Inserted Central Catheters Insertion and General Intravenous Access in Terminally Ill Cancer Patients: A Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- IV access maintenance success rate
研究概览
简要总结
To establish the IV access strategy for terminally ill cancer patients, using comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (optional PICC group).
详细描述
Reliable intravenous (IV) access is an important issue in terminally ill cancer patients, however, they have limited or no peripheral venous access due to edema or long period of IV therapy. Thus, intravenous access has been provided by Central venous catheter (CVC).
There are some options for applying CVC in cancer patients; subclavian venous catheter (SVC), chemo-port (CP), and the peripherally inserted central catheter (PICC).
When considering the characteristics of terminally ill cancer patients, such as poor general condition and a limited period of survival, PICC could be a safe and effective method for intravenous access.
There are two previous studies concerned about PICC study in terminally ill cancer patients. They showed that PICC might be overall safe and efficient in terminally ill cancer patients. However, these studies did not evaluate superiority of PICC insertion compared to no insertion and the appropriate time for PICC insertion due to limitation of their design, such as retrospective or single-arm observational study. Thus, strategies of PICC insertion for IV access in terminally ill cancer patients have not been determined until now.
Considering the favorable results of PICC insertion in previous studies and limited survival time of terminally ill cancer patients, the investigator postulated that routine PICC insertion at the time of admission for terminal care would be effective for IV access.
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
- •Cancer patients with histologically or cytologically confirmed malignancy and fulfilled all of the following conditions
- •Patients with expected survival time of 3 months or less due to a progressive disease without additional anticancer treatment. (However, palliative radiation treatment for symptom control is allowed.)
- •Patients who need the IV access route continuously for hydration or medication.
- •Age18 or older
- •Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed about all pertinent aspects of the trial prior to enrollment
排除标准
- •Patients who showed severe coagulopathy such as thrombocytopenia (Platelet count ≤ 20,000/mm2) or international normalized ratio (INR) prolongation (≥2.0 ) in spite of treatment
- •Patients who have an evidence of current sepsis (bacteremia or fungemia)
- •'current' means bacteremia/fungemia without eradication on follow-up peripheral blood culture
- •patients with persistent fever (bacteremia or fungemia cannot be ruled out)
- •Patients who is impracticable to PICC insertion due to uncontrolled behavioral disorders
结局指标
主要结局
IV access maintenance success rate
时间窗: From date of enrollment until death or discharge/transfer, assess up to 2 years
rate of successful PICC maintenance until death or discharge/transfer
次要结局
- patient perceived procedure-related distress(5th day after procedure)
- PICC related complication rate(From date of enrollment until death or discharge/transfer, assess up to 2 years)
- patient perceived comfort and convenience assessed by a newly developed question in this study(3th to 7th day after enrollment)
- colonization of microbiology in PICC(at the time of PICC removal, assess up to 2 years)
- PICC premature removal rate(From date of enrollment until date of PICC removal, assess up to 2 years)
- PICC life span(From date of enrollment until death or discharge/transfer, assess up to 2 years)
研究者
Kwonoh Park, MD phD
Professor, clinical research
Pusan National University Yangsan Hospital