Clinical Trial: Prolonging the Duration of Peripheral Venous Catheters in Cystic Fibrosis People

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 Concen

Brief Summary:

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.

Detailed Summary:

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).
Sponsor: University of Florence

Current Primary Outcome:

  • 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; [ Time Frame: once a day ]
  • The number of days that the first short peripheral venous catheter used for the treatment course stays in situ before removal [ Time Frame: once a day ]


Original Primary Outcome:

  • 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;
  • The number of days that the first short peripheral venous catheter used for the treatment course stays in situ before removal


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Florence

Dates:
Date Received: January 3, 2007
Date Started: March 2007
Date Completion:
Last Updated: October 28, 2015
Last Verified: October 2015