Study About Complications of Totally Implanted Venous Access Devices

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00670579
Study type	Observational
Source	University of Florence
Contact
Status	Completed
Phase	N/A
Start date	May 2008
Completion date	September 2010

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms