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

NCT00670579 | Completed

• 1 other identifier: FFC#30/2008
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

TIVAD; complications; nursing; cystic fibrosis; implanted

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with CF and with a TIVAD implanted

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Cystic Fibrosis Center of Tuscany, Meyer Hospital

Florence, Tuscany, Italy

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 2, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: September 1, 2010
• Last Updated: August 23, 2011

Record last verified: 2011-08

Locations

IT (1)