Serviço de Hospital de Dia, Hospital de Braga
Braga, 4710-243, Portugal
Location status: Recruiting
NCT Number: NCT05411666
Central venous catheter (CVC) are intravascular devices used in clinical practice, namely to administer fluid therapy, parenteral nutrition, drugs, blood products, hemodynamic monitoring, also being a gateway to the collection of blood samples or laboratory monitoring.
The fully implanted central venous catheter (CVCTI) is a type of central venous access surgically placed, which is characterized by containing a subcutaneous reservoir that is accessed by puncturing the camera with a blunt needle, widely used in cancer patients. The fully implanted central venous catheter is recommended when there is a need for intermittent vascular access and of long duration.
The maintenance of the CVCTI, as it's the necessity, frequency, and method is subject of some controversy, with discrepancies between the various cancer centers and guidance documents, once they occur several different intervals and maintenance methods.
The objective of this study is to assess the necessity of frequent maintenance of fully implanted central venous catheter, still assuring its viability and holding the same or lower number incidence of complications.
Participants in this study are cancer patients with a CVC fully implanted for chemotherapy, in follow-up phase. Participants will be randomized in one of two arms: Maintenance with saline solution and no maintenance.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Braga, 4710-243, Portugal
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Saline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun, according to local standard procedures.
Other names: Saline solution maintenance
No maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun. Just visual inspection to local site of CVC insertion.
Other names: No maintenance
Time frame: Time since screening until follow-up visit (on average 20 months)
The occurrence of any adverse event related to the use of the CVCTI, thus allowing to assess the difference between the 2 groups with as much data as possible.
Time frame: Time since screening until follow-up visit (on average 20 months)
The occurrence of adverse events related to infectious complications in the 2 groups.
Time frame: Time since screening until follow-up visit (on average 20 months)
The occurrence of adverse events related to thrombotic complications of both CVCTI and venous thrombosis in both groups.
Contact information is provided by the study sponsor or research team.
Clinical Academic Center (2CA-Braga)
Other
Acronym: OTIMACAT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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