Catheter ObstructionPhase 2NCT05084040
Non-inferiority of Clinical Trials in Comparison With the Length of Totally Implemented Porth-a-Cath Maintenance From 60 Versus 90 Days
A Phase 2 study testing 90 days interval between catheter maintenance in people with Catheter Obstruction, run by AC Camargo Cancer Center at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Catheter Obstruction
- What is being tested?
- 90 days interval between catheter maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Sep 2021to 1 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Use of any type of anticoagulant / antiplatelet drugs.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
A.C.Camargo Cancer Center
São Paulo, 01509-010
Jose Luiz Gasparini Junior, RN, +5511972873514, jose.gasparini@accamargo.org.br
About this study
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.
Read the 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.
- Conditions
- Catheter Obstruction
- Being tested
- 90 days interval between catheter maintenance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90 days interval between catheter maintenanceOther
Length of time between catheter maintenances extended from 60 days to 90 days
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Porth-a-Cath maintenance with 60-day interval |
| B | Experimental | Porth-a-Cath maintenance with 90-day interval Receives: Other: 90 days interval between catheter maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 1 year
Secondary outcomes (1)
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start15 Sep 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Luiz Gasparini-Jr, RN, MSc, Principal investigator, AC Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084040
- Sponsor's protocol ID
- 2663-19
- Status last verified
- Sep 2021
- First submitted
- 13 Aug 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority of Clinical Trials in Comparison With the Length of Totally Implemented Porth-a-Cath Maintenance From 60 Versus 90 Days
- ClinicalTrials.gov ID
- NCT05084040
- Acronym / sponsor ID
- 2663-19
- Conditions
- Catheter Obstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Porth-a-Cath maintenance with 60-day interval |
| B | Experimental | Other: 90 days interval between catheter maintenancePorth-a-Cath maintenance with 90-day interval |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Use of any type of anticoagulant / antiplatelet drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 90 days interval between catheter maintenanceLength of time between catheter maintenances extended from 60 days to 90 days | Other | B |
Primary outcome
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 secondary outcome
Financial toxicity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Luiz Gasparini-Jr, RN, MSc principal investigator
AC Camargo Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 90 days interval between catheter maintenance in people with Catheter Obstruction, run by AC Camargo Cancer Center at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Luiz Gasparini-Jr, RN, MSc (+5511972873514, jose.gasparini@accamargo.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter obstruction or catheter-related infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.