Non-inferiority of Clinical Trials in Comparison With the Length of Totally Implemented Porth-a-Cath Maintenance From 60 Versus 90 Days
NCT ID: NCT05084040
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
410 participants
INTERVENTIONAL
2021-09-15
2023-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1.1. Study design
Recruitment will take place during three months in the chemotherapy ambulatory at A.C. Camargo Cancer Center. Patients will be invited to participate in this study once they undergo maintenance of the fully implanted catheter (FIC), according to institutional routine. If the invited patient meets the inclusion and exclusion criteria defined in this study, he will respond to the financial assessment (Appendix 1). In the next step, he will be instructed to wait for the researcher to contact him to inform the next day of catheter maintenance.
After the clinical findings and randomization assessment, the patient will be informed to which group he belongs and he will be responsible for scheduling the next maintenance appointment, according to the group to which he belongs.
The study researcher will be responsible for checking if all participants have planned and carried out their maintenance according to his group. He will make sure that they underwent the catheter maintenance in the recommended time period. The study will consist of two arms, with the control group consisting of patients undergoing catheter care every 60 days as recommended in the current institutional protocol. The experimental group will consist of patients who will have a maintenance every 90 days.
Patients will be followed up for one year, with those randomized to the control group having 6 appointments and the experimental group having 4 appointments, in addition to the recruitment period. During follow-up, nurses responsible for this procedure will evaluate the development of specific mechanical complications related to the catheter. A graduated scale of 1 to 5 will be applied: Grade 1 - no resistance to saline infusion with venous return; Grade 2 - no resistance to saline infusion without venous return; Grade 3 - resistance to saline infusion with venous return; Grade 4 - resistance to saline infusion without venous return; Grade 5 - inability to infuse saline without venous return (obstructed). This rating will be recorded on the puncture procedure form already available in the health sector.
In the patient´s cases that will present obstruction in the totally implanted catheter, they will be forwarded to the emergency service. So, the medical teams will evaluate them to verify any possibility to use tissue plasminogen activator (t-PA). In cases of catheter infection, the patient will follow the institutional routine guide of treatment. The puncture procedure will follow the institutional pattern that was validated with the Hospital Infection Control Service.
1.2. Data assessment This study is expected to enrol 410 patients, 205 in the control group and 205 in the experimental group. 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% (14).
There are no studies indicating the obstruction rate for the experimental group, so an estimate was made to find the calculated values. If the volume was not collected in the first few months as planned, recruitment may be extended to the two years of this study, during which time as many patients as possible will be recruited.
In the randomization, sequential allocation will be applied (15). As a confusing variable, will be controlled gender and age. As a tool of randomization, an institutional website will be used https://estatsaude.shinyapps.io/alocacao/.
All patients have "intention to treat" and they will be analyzed in the groups they were in until the end of this study. Patients who have more than one event will be counted in each event of the analysis. After data collection, a descriptive analysis will be made. Then the absolute frequency of distribution and relative for qualitative variables and the main measures such as mean, median, and standard deviation and minimum and maximum for quantitative variables.
In order to evaluate a possible association between two qualitative variables, the independence test ( Chi-Square Test or Fisher's exact test) will be used. To compare quantitative variables concerning two independent groups, a non-parametric test of Mann-Whitney or T-test will be used.
Logistic regression models will be applied to evaluate association with clinical and socioeconomic variables of groups between those who will presented or not will presented obstruction of infection of the catheter. The adopted level of significance will be of 5% and the SPSS® for Windows® program, version 22.0 will be used.
1.3. Expected Results This study aims to demonstrate that saline maintenance every 90 days compared with 60-days maintenance does not result in more obstructions or infections in patients undergoing clinical follow-up.
1.4. Possible limitations of this study
The main limitations of this study are that it is a single center study, recruitment difficulty, and decreasing number of participants during follow-up.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Porth-a-Cath maintenance with 60-day interval
No interventions assigned to this group
B
Porth-a-Cath maintenance with 90-day interval
90 days interval between catheter maintenance
Length of time between catheter maintenances extended from 60 days to 90 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
90 days interval between catheter maintenance
Length of time between catheter maintenances extended from 60 days to 90 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Consent to participate by signing the consent form.
* No intravenous antineoplastic therapy regimen schedule (clinical follow-up).
* To have a functioning, fully implantable catheter with venous return, no resistance during solution infusion, no obstruction or evidence of infection at the time of recruitment.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AC Camargo Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
José Luiz Gasparini-Jr, RN, MSc
Role: PRINCIPAL_INVESTIGATOR
AC Camargo Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
A.C.Camargo Cancer Center
São Paulo, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2663-19
Identifier Type: -
Identifier Source: org_study_id