- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05084040
Non-inferiority of Clinical Trials in Comparison With the Length of Totally Implemented Porth-a-Cath Maintenance From 60 Versus 90 Days
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
1.Patients and methods
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jose Luiz Gasparini-Jr, RN, MSc
- Phone Number: +5511972873514
- Email: jose.gasparini@accamargo.org.br
Study Locations
-
-
-
San Paolo, Brazil, 01509-010
- Recruiting
- A.C.Camargo Cancer Center
-
Contact:
- Jose Luiz Gasparini Junior, RN
- Phone Number: +5511972873514
- Email: jose.gasparini@accamargo.org.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants over 18 years old
- 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:
- Use of any type of anticoagulant / antiplatelet drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: A
Porth-a-Cath maintenance with 60-day interval
|
|
Experimental: B
Porth-a-Cath maintenance with 90-day interval
|
Length of time between catheter maintenances extended from 60 days to 90 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of catheter obstruction or catheter-related infection
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Financial toxicity
Time Frame: 1 year
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: José Luiz Gasparini-Jr, RN, MSc, AC Camargo Câncer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2663-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Catheter Obstruction
-
TriHealth Inc.CompletedObstruction; Catheter, Infusion Catheter (Vascular) | Catheter; Complications (Indwelling Catheter)United States
-
TriHealth Inc.TerminatedObstruction; Catheter, Infusion Catheter (Vascular) | Catheter; Complications (Indwelling Catheter)United States
-
Boehringer IngelheimCompletedVascular Access Devices | Catheter ObstructionRussian Federation
-
Guang'anmen Hospital of China Academy of Chinese...RecruitingCatheter-related-bladder DiscomfortChina
-
Damanhour Teaching HospitalRecruitingCatheter Complications | Catheter Blockage | Catheter Dysfunction | Epidural; Anesthesia | Catheter BreakageEgypt
-
University of PennsylvaniaGenentech, Inc.TerminatedDialysis Catheter Fibrin Sheath | Clotted Dialysis Catheter | Catheter MalfunctionUnited States
-
Gülçin Özalp GerçekerCompletedCatheter Complications | Catheter LeakageTurkey
-
Boston Children's HospitalCompletedCatheter Related Complication | Dislodged CatheterUnited States
-
Poitiers University HospitalCompletedIntravascular-catheter Colonization | Catheter FailureFrance
-
B. Braun Ltd. Centre of Excellence Infection ControlTerminatedComplications; Catheter, Urinary (Indwelling Catheter) (Suprapubic)Belgium, Germany, Switzerland
Clinical Trials on 90 days interval between catheter maintenance
-
Memorial Sloan Kettering Cancer CenterGenentech, Inc.; Weill Medical College of Cornell UniversityCompletedGastric Cancer | Esophageal CancerUnited States
-
Memorial Sloan Kettering Cancer CenterBristol-Myers SquibbCompletedLeukemia | Acute Lymphoblastic LeukemiaUnited States