NCT05411666

Maintenance Optimization of the Fully Implanted Venous Catheter

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Clinical Academic Center (2CA-Braga) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cancer

Interventions

Type	Name	Description
PROCEDURE	Saline solution maintenance of the CVC	Saline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B\|Braun, according to local standard procedures.
PROCEDURE	No maintenance of the CVC	No maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B\|Braun. Just visual inspection to local site of CVC insertion.

Timeline

• Start date: 2020-06-30
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2022-06-09
• Last updated: 2025-08-15

Locations

1 site across 1 country: Portugal