Prolonging the Duration of Peripheral Venous Catheters in Cystic Fibrosis People

This study has been terminated.
(impossibility to find volunteers)
Sponsor:
Collaborators:
Italian Cystic Fibrosis Research Foundation, Verona, Italy
Ospedale Meyer
Information provided by (Responsible Party):
Filippo Festini, University of Florence
ClinicalTrials.gov Identifier:
NCT00418470
First received: January 3, 2007
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Cystic Fibrosis
Phlebitis
Procedure: regular dilution of antibiotic in NS
Procedure: higher dilution of antibiotic in NS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Florence:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2007
Estimated Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418470

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

Publications:
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.

Responsible Party: Filippo Festini, Associate Professor, University of Florence
ClinicalTrials.gov Identifier: NCT00418470     History of Changes
Other Study ID Numbers: FFC #19/2006
Study First Received: January 3, 2007
Last Updated: August 22, 2011
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee

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

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

ClinicalTrials.gov processed this record on July 31, 2014