- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067245
Use of Tetrasodium EDTA Catheter Lock Solution for Patients on HTPN
The Use of Tetrasodium EDTA Catheter Lock Solution for Patients on Home Parenteral Nutrition: Ease of Use and Cost Analysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parenteral nutrition (PN) is a life-sustaining therapy required in patients who do not have a functioning gastrointestinal tract. This can be either second to surgical removal, or malfunction (such as in malabsorptive conditions and dysmotility). The intravenous provision of nutrition requires central venous access where a hyperosmolar nutrient solution can be infused. A variety of central venous catheters (CVCs) can be used, including peripherally inserted central catheters (PICC), tunneled catheters and implanted ports. The most common complication, and most frequent cause of hospitalization in patients on home PN is bloodstream infection.
There are several new devices or solutions that are being developed to be used as primary prophylaxis for CRBSI. These include catheters with antibacterial and/or anti-biofilm properties and different catheter lock solutions. Antibiotic lock solutions have been used for salvage of central venous catheters in confirmed CRBSI. However, it is not recommended as a primary prophylaxis due to the creation of resistant organisms. According to the United States Center for Disease Control (CDC), antibiotics 'should be used only to manage infection.' However, one antimicrobial solution, taurolidine, has not been found to promote the emergence of resistant bacterial strains and it has been used successfully as a lock solution to prevent CRBSI. Although an antibiotic may have anti-biofilm properties in high concentrations but it does not have anticoagulant properties. Ethanol lock solutions (varying concentrations, but usually 70%) have also been used successfully to reduce CRBSI, however, there have been adverse events when they are used in polyurethane lines and it does not inherently have anticoagulant properties. Historically, citrate lock solution has also been used to maintain catheter patency, but in a meta-analysis, there was no difference between heparin and citrate lock with regards to catheter thrombosis or catheter related bloodstream infection.
Although its use has been evaluated in hemodialysis catheters, there are no known studies examining the use of a tetra-sodium EDTA catheter lock solution in central venous catheters of patients on home PN. Although both hemodialysis and home PN require central venous catheters, there are many differences inherent to the different usages. First, the types of catheters that are used can differ. There is more variety in the types of catheters used for home PN. Second, most patients undergo hemodialysis on a fixed schedule, three times per week for 4 to 8 hours each time, and, for the majority of patients, this is done in-center, with the assistance of a nurse. On the other hand, home PN is usually administered five or more days per week, at home, over 12 or more hours. It can be either administered with the assistance of a home care nurse or by the patient and/or their family/partner. Furthermore, the substance infused through the catheter is different. Specifically, amino acids and fat emulsions are usually only infused in home PN, although electrolytes and fluids can be infused in both.
Kitelock™, 4% tetrasodium EDTA catheter lock solution is the sole product of SterileCare Inc, a private medical devices and equipment company registered federally in Canada, and based in Markham, Ontario. Kitelock™ is licensed as a medical device, class 2 (license #96962, issue date 2016-05-10), by Health Canada.
The aim of this study is to perform cost- and ease-of-use analyses in patients on home parenteral nutrition.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johane Allard
- Phone Number: 4163405159
- Email: dr.johane.allard@uhn.ca
Study Contact Backup
- Name: Katherine Schwenger
- Phone Number: 4163404413
- Email: kschweng@uhnresearch.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- Recruiting
- Toronto General Hospital
-
Contact:
- Johane Allard, MD, FRCPC
- Phone Number: (416) 340-5159
- Email: johane.allard@uhn.ca
-
Contact:
- Katherine Schwenger, PHD
- Phone Number: 4413 (416)340-5159
- Email: kschweng@uhnresearch.ca
-
Sub-Investigator:
- Ennaliza Salazar, MBCHB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult over the age of 18
- Both males and females
- Clinically stable for at least 4 weeks with no acute medical co-morbidities
Exclusion Criteria:
- Inability to give informed consent
- Alcohol or drug abuse
- Pregnant and lactating women
- Clinical instability such as the following:
- Acute pulmonary edema
- Decompensated heart failure
- Decompensated chronic liver disease
- Severe post-traumatic conditions
- Uncontrolled diabetes mellitus
- Acute myocardial infarction
- Acute stroke
- Acute thromboembolism
- Metabolic acidosis
- Sepsis
- Hypotonic dehydration
- Coagulopathy with prolonged aPTT or INR
- Unstable oncology patient
- Subjects who are hypersensitive or allergic to the product ingredients of tetrasodium EDTA
- Active therapy with long-term anti-microbial, such as taurolidine (not including patients receiving intermitted antimicrobial treatment for small intestinal bacterial overgrowth)
- Active participation in another home TPN clinical trial which may interfere with the results
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Tetrasodium EDTA cathether lock solution
There is only one arm in this study where home parenteral nutrition patients who meet the inclusion criteria will receive tetrasodium EDTA catheter lock solution.
|
Home parenteral nutrition patients who meets inclusion criteria is to receive tetrasodium edta catheter lock solution.
Patient will receive standard catheter lock solution of heparin/saline for 1 month, followed by tetrasodium EDTA catheter lock solution using withdrawal method for 1 month and followed by tetrasodium EDTA catheter lock solution using flush method for 1 month.
In total, patient will stay in the study for 3 months.
A phone call will be conducted before the start of the study to give instruction to patient regarding the use of catheter lock solution.
Time taken to connect and disconnect TPN will be recorded by patients, twice a month on first and last mondays of the month for 3 months.
A survey regarding the ease of use of catheter lock solution will be conducted at the end of each month via phone by nurse coodinator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ease of use
Time Frame: 24 months
|
Acceptability of the new catheter lock solution by administering a questionnaire survey that will be conducted by the end of the usage.
The questionnares will require the participant to rate the overall satisfaction of the product as '1.
unsatisfied or 2. neutral or 3. satistified' and to rate the amount of time it takes to prepare the product as '1.
took long or 2. neutral or 3. doesn't take too long and 3rd question compared to usual product (heparin), how easy is this product as '1.
harder than heparin or 2. the same or 3. easier than heparin' and last question is ask if participant would continue to use this lock solution 'Yes' or 'No' and why not?
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time taken to use the catheter lock
Time Frame: 24 months
|
To evaluate time required to use the catheter lock solution by recording time taken to connect and disconnect TPN on the first and last Monday of every month.
|
24 months
|
Cost analysis
Time Frame: 24 months
|
Cost analysis of using tetrasodium EDTA catheter lock solution versus heparin saline catheter lock solution
|
24 months
|
Collaborators and Investigators
Investigators
- Study Chair: Ennaliza Salazar, TPN team
Publications and helpful links
General Publications
- Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum In: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.
- Zhao Y, Li Z, Zhang L, Yang J, Yang Y, Tang Y, Fu P. Citrate versus heparin lock for hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. Am J Kidney Dis. 2014 Mar;63(3):479-90. doi: 10.1053/j.ajkd.2013.08.016. Epub 2013 Oct 11.
- Percival SL, Kite P, Eastwood K, Murga R, Carr J, Arduino MJ, Donlan RM. Tetrasodium EDTA as a novel central venous catheter lock solution against biofilm. Infect Control Hosp Epidemiol. 2005 Jun;26(6):515-9. doi: 10.1086/502577.
- Kanaa M, Wright MJ, Akbani H, Laboi P, Bhandari S, Sandoe JA. Cathasept Line Lock and Microbial Colonization of Tunneled Hemodialysis Catheters: A Multicenter Randomized Controlled Trial. Am J Kidney Dis. 2015 Dec;66(6):1015-23. doi: 10.1053/j.ajkd.2015.04.047. Epub 2015 Jun 30.
- Banfi G, Salvagno GL, Lippi G. The role of ethylenediamine tetraacetic acid (EDTA) as in vitro anticoagulant for diagnostic purposes. Clin Chem Lab Med. 2007;45(5):565-76. doi: 10.1515/CCLM.2007.110.
- O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011 May;52(9):e162-93. doi: 10.1093/cid/cir257. Epub 2011 Apr 1. No abstract available.
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
Keywords
Other Study ID Numbers
- 18-6325.0
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.
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