Study About Complications of Totally Implanted Venous Access Devices (TIVADs) in People With Cystic Fibrosis (CF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Filippo Festini, University of Florence
ClinicalTrials.gov Identifier:
NCT00670579
First received: April 30, 2008
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

Pulmonary infections are the major cause of mortality and morbidity in cystic fibrosis (CF); patients frequently have to take antibiotics which often cannot be given orally or by aerosol but have to be administered intravenously. In order to reduce the number of venepunctures, totally implanted venous access devices (TIVAD) or Ports have been used to administer antibiotics and other infusions.

The use of Port systems has been increasing in recent years, especially for those patients requiring frequent intravenous treatments. Having a TIVAD in place makes venous access quicker and also reduces trauma, suffering and pain. However, there are important complications associated with TIVADs which can be early (pneumothorax, arterial puncture, severe bruising) or late (infections, thromboembolic complications and occlusion).

Although the use of TIVADs in CF is increasing, there is little CF-specific literature available on the epidemiology and risk of TIVAD complications. Also, literature is scarce about clinical criteria for deciding to insert a TIVAD. Therefore, so far clinical decisions were based mainly on experiences of TIVAD use in other diseases, such as cancer.

With this prospective observational study we will survey a large population of Italian CF people with TIVAD in order to: collect data about current clinical conditions of CF people with TIVAD; investigate about clinical criteria that led to the decision of positioning a TIVAD; observe the possible onset of late complications.


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study About Complications of Totally Implantable Central Venous Access Ports in People With CF

Resource links provided by NLM:


Further study details as provided by University of Florence:

Primary Outcome Measures:
  • To determine the incidence of late complications (infectious, thrombotic and obstructive) in CF people with a totally implanted venous access devices and to investigate possible associations between the onset of complications and several variables [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: May 2008
Study Completion Date: September 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:

To be included in the study, subjects need to fulfil the following requirements:

  • Diagnosis of CF, made accordingly to the CF Foundation Guideline;
  • Ability to consciously express owns informed consent, if aged 18 or more. If minor, presence of at least one legally authorised parent able to consciously express informed consent;
  • Have a TIVAD implanted;
  • Have no current complications in the TIVAD (infection, thromboembolic complications or occlusion) Outcome Measures

Measured outcomes will be:

  1. Incidence of TIVAD infections (Port pocket infection, Cutaneous site infection,Catheter-related infection;
  2. Incidence of TIVAD thrombosis;
  3. Incidence of TIVAD occlusion.

The observational phase will last 12 months for each subject involved

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People with CF and with a TIVAD implanted

Criteria

Inclusion Criteria:

  • Diagnosis of CF, made accordingly to the CF Foundation Guideline
  • Ability to consciously express owns informed consent, if aged 18 or more. If minor, presence of at least one legally authorised parent able to consciously express informed consent
  • Have a TIVAD implanted
  • Have no current complications in the TIVAD (infection, thromboembolic complications or occlusion)
  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: NCT00670579

Locations
Italy
Cystic Fibrosis Center of Tuscany, Meyer Hospital
Florence, Tuscany, Italy
Sponsors and Collaborators
University of Florence
  More Information

No publications provided

Responsible Party: Filippo Festini, Associate Professor, University of Florence
ClinicalTrials.gov Identifier: NCT00670579     History of Changes
Other Study ID Numbers: FFC#30/2008
Study First Received: April 30, 2008
Last Updated: August 22, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Florence:
TIVAD
complications
nursing
cystic fibrosis
implanted

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014