Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05084040
Status:
UNKNOWN
Last Update Posted:
2021-10-19
First Post:
2021-08-13
Brief Title:
Non-inferiority of Clinical Trials in Comparison With the Length of Totally Implemented Porth-a-Cath Maintenance From 60 Versus 90 Days
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Non-inferiority of Clinical Trials in Comparison With the Length of Totally Implemented Porth-a-Cath Maintenance From 60 Versus 90 Days
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 drugs 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 ACCamargo 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:
1Patients and methods
11 Study design
Recruitment will take place during three months in the chemotherapy ambulatory at AC 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 patients 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
12 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 135 in obstruction in the control group based on a retrospective study 8 and 20 of obstruction in the experimental group with study margin of 25 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 httpsestatsaudeshinyappsioalocacao
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 Fishers 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 220 will be used
13 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
14 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
11 Study design
Recruitment will take place during three months in the chemotherapy ambulatory at AC 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 patients 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
12 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 135 in obstruction in the control group based on a retrospective study 8 and 20 of obstruction in the experimental group with study margin of 25 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 httpsestatsaudeshinyappsioalocacao
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 Fishers 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 220 will be used
13 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
14 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None