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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05084040
Other study ID # 2663-19
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 15, 2021
Est. completion date January 1, 2023

Study information

Verified date September 2021
Source AC Camargo Cancer Center
Contact Jose Luiz Gasparini-Jr, RN, MSc
Phone +5511972873514
Email jose.gasparini@accamargo.org.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Abstract: Antineoplastic therapy (AT) is one of the most used treatment modalities to fight cancer, either curatively or palliatively. There are several possible routes of administration, but the intravenous is the most used for its safe absorption and maintenance of the drug's serum level (1). Among the central catheters used in oncology, the long-term Totally Implantable (CTI) catheter is one of the most well accepted by patients and healthcare professionals. Being used in the administration of fluids, medication, parenteral nutrition or to obtain blood. Maintaining the CTI is essential to maintain its permeability, and thus, its proper functioning (2-4). The COVID-19 pandemic requires several readjustments from health institutions to ensure healthy environments for patients and less exposure to the hospital environment, one of the measures to focus on increasing the maintenance time of the ICU from 30 to 60 days. Objective: To verify the safety of increasing the maintenance interval of the Port-a-Cath catheter from 30 to 60 days through the rate of infection, obstruction, dysfunction in the infusion of solutions and blood reflux at the end of a year of follow-up. Method: This is an observational study, a single research arm, with a scheduled duration from January 2021 to August 2022 at the chemotherapy clinics of the A.C.Camargo Cancer Center. Expected results: This investigation is expected to demonstrate that maintenance with saline every 60 days does not increase obstruction or infection in patients who are in clinical follow-up compared to maintenance for 30 days.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
90 days interval between catheter maintenance
Length of time between catheter maintenances extended from 60 days to 90 days

Locations

Country Name City State
Brazil A.C.Camargo Cancer Center San Paolo

Sponsors (1)

Lead Sponsor Collaborator
AC Camargo Cancer Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of catheter obstruction or catheter-related infection This evaluation will be performed using the power test with 80% , significance level of 5%, and a rate of 1.35% in obstruction in the control group based on a retrospective study (8) and 2.0% of obstruction in the experimental group with study margin of 2.5% 1 year
Secondary Financial toxicity Identifying the impact of the economic burden associated with central catheter maintenance with compare groups. The questionnaire has six questions and was produced by the researcher. It will be identified: Work situation (working or not), cost of food, transport, and time on the maintenance day. In addition to the form of health cost (insurance or private) 1 year
See also
  Status Clinical Trial Phase
Completed NCT01958164 - Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device Occlusion Phase 3