Prolonging the Duration of Peripheral Venous Catheters in Cystic Fibrosis People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00418470
Recruitment Status : Terminated (impossibility to find volunteers)
First Posted : January 4, 2007
Last Update Posted : October 29, 2015
Italian Cystic Fibrosis Research Foundation
Ospedale Meyer
Information provided by (Responsible Party):
Filippo Festini, University of Florence

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.

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Phlebitis Procedure: regular dilution of antibiotic in NS Procedure: higher dilution of antibiotic in NS Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Concentrations of Antibiotic in Normal Saline
Study Start Date : March 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Higher concentration of antibiotic in NS
Procedure: regular dilution of antibiotic in NS
IV administration of ceftazidime tid diluted in regular NS volume
Experimental: B
Lower concentration of antibiotic in NS
Procedure: higher dilution of antibiotic in NS
IV administration of ceftazidime tid diluted in larger NS volume

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00418470

Meyer Pediatric Hospital (Ospedale Pediatrico Meyer)
Florence, Italy, 50132
Sponsors and Collaborators
University of Florence
Italian Cystic Fibrosis Research Foundation
Ospedale Meyer
Principal Investigator: Filippo Festini, RN, BA, BSN University of Florence, Department of Pediatrics

Cystic Fibrosis Foundation. Patient Registry 2004 Annual Report. Bethesda, Maryland
Littlewood J, Bevan A, Commet G, Govan J. Antibiotic treatment for cystic fibrosis. Cystic Fibrosis Trust 2002. Bromley, UK
Gronowitz E, Strandner K, Herlitz K et all. A national Swedish survey of totally implantable venous access devices (TIVAD) in patients with Cystic Fibrosis (CF). J Cyst Fibros 2003;2:S72
Proesmans M, Boulanger L, De Boeck K. Complications with indwelling catheters in CF patients followed at the universital hospital in Leuven (Belgium). J Cyst Fibros 2002;S172-S173.
The UK CF Nurse Specialist Group. National consensus standards for the nursing management of cystic fibrosis. London, UK7 Cystic Fibrosis Trust; 2001.
Duncan-Skingle F, Bramwell E. Cystic Fibrosis Home care. In: Hodson ME, Geddes DM. Cystic Fibrosis. Arnold, London, 2000.
Neri S, Allegretti N, Vignoli N, FESTINI F. Perception of pain and fear related to invasive procedures in children with cystic fibrosis: a study using CF adults recalls. J Cyst Fibros 2006; 5 (suppl1): 91.
FESTINI F, Beneventi R, Allegretti N, Vignoli N, Chiarelli F. Does oral anti.inflammatory therapy influence the duration of peripheral venous catheters used for IV antibiotic cycles in cystic fibrosis patients ? Pediatr Pulmonol 2005; Suppl 28: 359-360.
FESTINI F, Bongini G, Vignoli N, Sanasi S, Campigatto E, Allegretti N, Rontini I, Grondoni G. The number of daily IV administrations of antibiotics influences the duration of peripheral venous catheters in cystic fibrosis patients. Pediatr Pulmonol 2002; suppl 24:356.
Ballarin S, Codamo T, Doro R, Loganes C, FESTINI F. Pain in Italian Cystic Fibrosis adult patients: preliminary results of a national nurse led study. J of Cystic Fibrosis 2001; 1: 362.
Alexander M (editor) Infusion Nursing Standard of Practice of the Intravenous Nurses Society. Journal of Intravenous Nursing 2000; 23. 6S.
Hockenberry MJ. Wong's clinical manual of pediatric nursing. Mosby 2004, St Louis, Missouri.

Responsible Party: Filippo Festini, Associate Professor, University of Florence Identifier: NCT00418470     History of Changes
Other Study ID Numbers: FFC #19/2006
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015

Keywords provided by Filippo Festini, University of Florence:
Cystic fibrosis
Catheterization, peripheral
Anti-Bacterial Agents
Osmolar Concentration

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents