Prolonging the Duration on Site of Short Peripheral Venous Catheters Used to Administer Intravenous Antibiotics in Cystic Fibrosis Adults. Randomized Controlled Trial on the Effect of Different Concentrations of Antibiotic in Normal Saline
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The irritation level of the first vein that is cannulated for the course assessed each day. The assessment will be done utilizing the "Phlebitis Scale" of the Standard of Practice of the Intravenous Nurses Society (Journal of Intravenous Nursing 2000;
研究概览
简要总结
Patients with cystic fibrosis (CF) need to frequently undergo courses of IV antibiotic therapy. To avoid a high number of venipunctures peripheral venous catheters (SPVC) or cannulas are used. Because of the irritant action of the drugs used, SPVC's often do not last for the whole antibiotic course (usually of two weeks) and the patient has to be punctured again for the insertion of a new IV line. With the passing of time the veins are more difficult to be found. An alternative to the use of a cannulas is the surgical insertion of a central venous catheter. This intervention may have contraindications or, specially in adolescents, cause unacceptable alterations of the body image.
The aim of this study is to find a way to prolong the duration of the SPVC used by CF patients during antibiotic courses avoiding the irritation of the vein or a phlebitis.
Design of the study: randomized controlled trial. The study will see a collaboration of nurses, physicians and technicians of the Tuscan CF Centre.
The patients that will participate at the study will be randomly assigned to one of the two groups: one group will receive the antibiotics prescribed according to the maximal dilution suggested by the pharmaceutical company, the other will receive a much higher dilution (i.e. a higher volume of Normal Saline), but the time of administration will be the same.
The assessment will regard: the level of inflammation of the vein (with a special visual scale) and the duration of the SPVC.
The hypothesis that is to be proved is that diluting the antibiotic in a higher volume of Normal Saline it is possible to delay or prevent the irritation of the vein and the onset of a phlebitis.
In case that the hypothesis will be confirmed by this study an easy, secure, low cost and immediately available system will be available to reduce the number of venipunctures necessary to complete a course of IV antibiotics.
详细描述
Background
Cystic Fibrosis (CF) is a common genetic disease which affects, among other organs, the respiratory tree. The major cause of mortality and morbidity in CF are pulmonary infections caused by a limited number of bacteria, in particular gram negative bacteria such as Pseudomonas aeruginosa (PA) and Burkholderia cepacia complex (BCC) which cause frequent clinically acute pulmonary infections.
Current figures show that 57.3% of patient have their lungs infected by PA and 2.9% of them have their lungs infected by BCC (1). To fight pulmonary exacerbations, patients frequently have to undergo antibiotic treatments, which often cannot be given orally or by aerosol but have to be administered intravenously (IV). Some CF Centers have also adopted a treatment protocol for patients chronically infected by respiratory pathogens in which a prophylactic IV course of antibiotic is routinely given every 3 months even in the absence of clinical symptoms of pulmonary exacerbations (2) An IV course of antibiotic treatment should be continued for at least 10 days but usually it lasts 2 weeks (3). Completing it would therefore require doing numerous venipunctures to a patient. In the USA, during 2004 some 45% of patients aged 18 to 30 required at least 1 IV antibiotic course, about 25% 2 IKV course and 15% 3 courses or more (1). This IV treatment regime brings a relevant burden of pain, anxiety and a worsening of quality of life (4). In order to reduce the number of venipunctures needed for an antibiotic course, several intravenous indwelling devices have been used to administer antibiotic infusion.
Some of these venous catheters are inserted in a central vessel. Among them, port caths and Groshong or Broviac type Central catheters, Midline catheters are those most commonly used (5-9). They are intended to last from several weeks to years. Their insertion requires a surgical intervention. Such an invasive intervention may not be sometimes indicated due to the patient's clinical condition. Moreover, the presence of a permanent device may influence the patients' body image and autonomy, with negative consequences in the psychological condition of the patient, especially in adolescence (10). Also, systemic infections may occur (11), the permanent management of the device may result complicated (12-15) and it may influence the patient's day-to-day life. Recently, a high incidence of thrombosis related to the insertion of this kind of catheters has been described (16) The most commonly used type of IV device to administer antibiotics in CF is the short peripheral venous catheter (SPVC) or cannula (17, 18) which has been considered for long now the simplest, most easy-to-use and economic way for administering IV therapy in CF. The use of this device allows patients not to be punctured at every administration and to eventually perform the antibiotic course at home avoiding hospitalisation and therefore maintaining a relatively normal daily life. Moreover, compared to the previously described permanent devices, this one is less invasive, it does not require a surgical intervention to be inserted, and it is intended to be maintained only for the duration of the treatment.
In order to facilitate CF people's autonomy and to reduce the conditioning of their quality of life, The home administration of IV antibiotic has become increasingly common (17-21). In 2004, 20.1% of US CF patients received home IV treatment (1). Patients themselves and their relatives are often trained by CF Centers' Nurses on how to manage the administration of the antibiotic treatment on their own.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 cystic fibrosis, made accordingly to the Cystic Fibrosis Foundation Guideline (Rosenstein BJ. J Pediatr 1998;132: 589-595)
- •age of 18 years or more and ability to consciously express owns informed consent.
- •have a prescription done by one of the CF Centre specialist Physicians of an IV antibiotic course of the expected duration of 2 weeks, due to a pulmonary exacerbation, with the association of ceftazidime 3 times daily and tobramycin once daily diluted in Normal Saline.
- •absence of clinical conditions that contraindicate the administration of 350ml of Normal Saline in 30 minutes 3 times daily and of 400ml of Normal Saline in 40 minutes.
- •no simultaneous anti-inflammatory therapy administered orally, IM or IV
- •30 days have passed from the end of the previous course.
- •The IV course will be given to the subject as an inpatient, and he or she will be admitted to our hospital
排除标准
- 未提供
结局指标
主要结局
The irritation level of the first vein that is cannulated for the course assessed each day. The assessment will be done utilizing the "Phlebitis Scale" of the Standard of Practice of the Intravenous Nurses Society (Journal of Intravenous Nursing 2000;
时间窗: once a day
The number of days that the first short peripheral venous catheter used for the treatment course stays in situ before removal
时间窗: once a day
次要结局
未报告次要终点
研究者
Filippo Festini
Associate Professor
University of Florence
