Tetrasodium EDTA for Catheter Complications

Overseen By Johane Allard

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Long-term antimicrobials

Disqualifiers: Alcohol, Drug abuse, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

20 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on long-term antimicrobial therapy like taurolidine, you cannot participate in the trial.

What data supports the idea that Tetrasodium EDTA for Catheter Complications is an effective treatment?

The available research shows that Tetrasodium EDTA is effective in eradicating biofilms, which are groups of microorganisms that stick to surfaces like catheters. In one study, Tetrasodium EDTA was able to eliminate almost all biofilm from catheters removed from hemodialysis patients. Another study found that it was effective against various types of microorganisms, including bacteria and fungi, that form biofilms on central venous catheters. This suggests that Tetrasodium EDTA can help prevent infections and extend the life of catheters, making it a promising alternative to antibiotics, which can lead to resistance. ^{1 2 3 4 5}

What safety data exists for Tetrasodium EDTA used in catheter complications?

The provided research does not contain specific safety data for Tetrasodium EDTA, T-EDTA, or KiteLock™ 4% Sterile Catheter Lock Solution. The studies focus on other compounds and their effects, such as ketorolac tromethamine and preservatives in eye drop formulations, but do not address the safety of Tetrasodium EDTA in catheter use. ^{6 7 8 9 10}

Is Tetrasodium EDTA a promising treatment for catheter complications?

The provided research articles do not contain information about Tetrasodium EDTA or its effectiveness for catheter complications, so we cannot determine if it is a promising treatment based on this data. ^{11 12 13 14 15}

What is the purpose of this trial?

Parenteral nutrition (PN) is a lifesaving therapy in patients with chronic intestinal failure. PN is administered via a central venous catheter (CVC), and patients are dependent on this line for ongoing nutrition. However, the presence of a CVC is associated with a risk of thrombosis and bloodstream infection. Many different types of catheter lock solutions have been used to mitigate these risks. They include solutions primarily aimed at reducing thrombosis, such as heparin and citrate, and others primarily aimed at reducing infection such as ethanol and antibiotics (for example, taurolidine). One recently developed solution, tetrasodium EDTA, aims to reduce both thrombosis and infection. This scientific review provides an overview of central venous catheter lock solutions, and an ease-of-use and cost analysis comparing heparin and tetrasodium EDTA in one home parenteral nutrition program in Toronto, Canada.

Research Team

Ennaliza Salazar

Principal Investigator

TPN team

Eligibility Criteria

This trial is for adults over 18 who are stable on home total parenteral nutrition (HTPN) without acute illnesses. It's not for those allergic to tetrasodium EDTA, unable to consent, with substance abuse issues, pregnant or breastfeeding women, or those with certain severe medical conditions.

Inclusion Criteria

My health has been stable for the last 4 weeks without any new serious illnesses.

I am either male or female.

I am over 18 years old.

Exclusion Criteria

I am on a long-term anti-microbial treatment, not for small intestinal issues.

You have a history of alcohol or drug abuse.

Pregnant and lactating women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tetrasodium EDTA catheter lock solution as part of their home parenteral nutrition regimen

24 months

Monthly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tetrasodium EDTA

Trial Overview The study tests a catheter lock solution called Tetrasodium EDTA in patients using HTPN. The goal is to see if it reduces complications like blood clots and infections better than other solutions such as heparin.

Participant Groups

Group I: Tetrasodium EDTA cathether lock solution Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of catheters removed from hemodialysis patients, tetrasodium EDTA was found to effectively eradicate biofilm bacteria after a 24-hour treatment, indicating its potential as a catheter lock solution.

The study identified 20 biofilm-positive isolates from catheters, with tetrasodium EDTA showing promise in reducing catheter-related infections, which could benefit patients with limited access to vascular sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of in vivo-generated biofilms from hemodialysis catheters to test the efficacy of a novel antimicrobial catheter lock for biofilm eradication in vitro. Kite, P., Eastwood, K., Sugden, S., et al.[2018]

Tetrasodium EDTA, an antimicrobial lock solution, was found to effectively eliminate biofilms formed by various bacteria and fungi on central venous access devices (CVADs), suggesting it could help prevent infections and extend the lifespan of these devices.

This solution offers a promising alternative to traditional antibiotics, potentially reducing the risk of antibiotic resistance while targeting the prevention of hospital-acquired bloodstream infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tetrasodium EDTA Is Effective at Eradicating Biofilms Formed by Clinically Relevant Microorganisms from Patients' Central Venous Catheters. Liu, F., Hansra, S., Crockford, G., et al.[2019]

The 4% tetrasodium EDTA infusion protocol was effective in relieving intraluminal obstruction in 68.8% of the 16 SUB devices treated in 14 cats, indicating its potential as a therapeutic option.

However, more than half of the successful cases (54.5%) experienced a recurrence of obstruction within a median of 87 days, highlighting the need for further research on case selection and treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of tetrasodium EDTA acid for the treatment of intraluminal obstruction of subcutaneous ureteral bypass devices. Duval, V., Dunn, M., Vachon, C.[2022]

Chelators like citrate and EDTA are effective alternatives to heparin in catheter lock solutions, offering benefits such as antimicrobial activity and maintaining catheter patency, which is crucial for patients with cancer or on hemodialysis.

The review highlights the safety and low cost of chelators, making them a promising option for preventing catheter-related bloodstream infections and ensuring the proper functioning of central lines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the prevention and management of central-line-associated bloodstream infections: The role of chelator-based catheter locks. Chaftari, AM., Viola, GM., Rosenblatt, J., et al.[2020]

The study found that a 30% concentration of ethanol is compatible with 4% trisodium citrate (TSC) for use as a catheter locking solution, while higher concentrations (35% or more) lead to crystallization.

Although the combination of ethanol and TSC did not alter TSC concentration in glass test tubes, a slight increase in TSC concentration was observed in carbothane hemodialysis catheters, indicating potential interactions that require further investigation before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethanol/trisodium citrate for hemodialysis catheter lock. Bell, AL., Gu, X., Burczynski, FJ., et al.[2019]

Patients who underwent a topical prednisolone acetate trial (PAT) before receiving intravitreal triamcinolone acetonide (IVTA) experienced a significantly lower proportional rise in intraocular pressure (IOP) compared to control patients, indicating a potential protective effect of the PAT.

The PAT group also had a reduced risk of severe IOP spikes and were less likely to require glaucoma surgery, suggesting that prior treatment with prednisolone acetate may enhance safety in patients receiving IVTA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A trial of topical prednisolone acetate before intravitreal triamcinolone acetonide decreases intraocular pressure spikes. Hollands, H., Seif, G., Hollands, S., et al.[2016]

Cefuroxime and ceftazidime showed limited microbicidal effects in unpreserved aqueous eye drop formulations, indicating that these antibiotics alone are not sufficient for preserving the formulations against microbial contamination.

Cefuroxime was effectively preserved in the artificial tear formulation Sno Tears, which contains benzalkonium chloride, while ceftazidime was less effectively preserved in the same vehicle but performed better than alternatives like phenylmercuric acetate and chlorhexidine acetate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preservative efficacy in cefuroxime and ceftazidime eye drop formulations. Barnes, AR., Nash, S.[2019]

The study found that the formulation of ketorolac tromethamine eye drops with preservatives like benzalkonium chloride and disodium edetate significantly enhanced the drug's permeation through corneas, indicating a potential for improved therapeutic effectiveness.

Increasing the viscosity of the eye drop formulation decreased the drug's permeation, suggesting that optimizing viscosity is crucial for maximizing drug delivery in ocular treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of preservative, antioxidant and viscolizing agents on in vitro transcorneal permeation of ketorolac tromethamine. Malhotra, M., Majumdar, DK.[2014]

The development of a topical solution for the corticosteroid tipredane involved a nonirritating cosolvent system that effectively dissolved the drug at a concentration of 0.1% w/w, ensuring safety for skin application.

Formulations using tromethamine as a buffering agent were more stable than those using potassium citrate, as the latter led to precipitation issues, highlighting the importance of selecting appropriate excipients for drug stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of cosolvent concentration and excipient composition in a topical corticosteroid solution. Varia, SA., Faustino, MM., Thakur, AB., et al.[2019]

The study identified Tween 60 and ethylene glycol as the most effective surfactant and cosurfactant, respectively, for enhancing the solubility of ketorolac tromethamine (KT) in ocular nanoemulsions, which is crucial for effective drug delivery.

Most surfactants tested were non-irritant to the conjunctiva, while some cosurfactants showed varying levels of irritation, indicating that careful selection of excipients is important for developing safe ocular formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Studies on Surfactants, Cosurfactants, and Oils for Prospective Use in Formulation of Ketorolac Tromethamine Ophthalmic Nanoemulsions. Smail, SS., Ghareeb, MM., Omer, HK., et al.[2021]

Staphylococcus epidermidis is a major cause of postoperative infections in orthopedic surgeries, leading to the use of antibiotics like cefazolin and cefuroxime for prevention, but increasing methicillin-resistant strains have necessitated the use of glycopeptide antibiotics like vancomycin and teicoplanin.

Regional prophylaxis with teicoplanin during total knee replacement surgery has been shown to be safe and effective, providing higher antibiotic concentrations at the surgical site and achieving similar infection rates compared to traditional systemic prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in orthopedic prosthetic surgery. de Lalla, F.[2022]

Postoperative intravenous tranexamic acid (TXA) significantly reduced total blood loss (TBL) and hidden blood loss (HBL) in patients undergoing total knee arthroplasty (TKA) compared to a placebo, with no significant differences between two dosing regimens of TXA.

The use of TXA did not increase the incidence of venous thromboembolism (VTE) or other complications, indicating it is a safe option for managing blood loss in TKA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Postoperative Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Prospective Randomized Controlled Study. Xue, CX., Yao, YF., Lv, H., et al.[2021]

In a study involving 60 total knee arthroplasties, QuikClot Combat Gauze (QCG) did not significantly reduce intraoperative bleeding compared to standard gauze, with similar bleeding volumes observed in both groups.

Postoperative blood drainage was slightly higher in the QCG group, and there was no significant difference in blood transfusion rates between the two types of gauze, indicating that QCG may not provide a hemostatic advantage in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Intraoperative Use of QuikClot Combat Gauze Effective for Hemostasis after Total Knee Arthroplasty? Noh, JH., Lee, JW., Nam, YJ., et al.[2018]

In a study of 90 patients undergoing total knee arthroplasty, both tranexamic acid (TXA) and Floseal® significantly reduced blood loss compared to a control group, as indicated by lower decreases in hemoglobin and total drain output.

Floseal® was found to be more effective than TXA in minimizing drain output, suggesting it may be a preferable option for reducing bleeding during surgery without increasing complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Floseal® and Tranexamic Acid for Bleeding Control after Total Knee Arthroplasty: a Prospective Randomized Study. Helito, CP., Bonadio, MB., Sobrado, MF., et al.[2022]

In a study involving 182 patients undergoing total knee arthroplasty, both intra-articular and intravenous administration of tranexamic acid (TXA) were found to be equally effective in controlling blood loss, with no significant difference in hemoglobin reduction post-surgery.

Both methods of TXA administration demonstrated similar safety profiles, as no patients required blood transfusions and there were no significant complications reported, indicating that either route can be safely used in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intra-articular versus intravenous tranexamic acid in reducing perioperative blood loss in total knee arthroplasty: a prospective randomized double-blind equivalence trial. Subramanyam, KN., Khanchandani, P., Tulajaprasad, PV., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of in vivo-generated biofilms from hemodialysis catheters to test the efficacy of a novel antimicrobial catheter lock for biofilm eradication in vitro. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Tetrasodium EDTA Is Effective at Eradicating Biofilms Formed by Clinically Relevant Microorganisms from Patients' Central Venous Catheters. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Use of tetrasodium EDTA acid for the treatment of intraluminal obstruction of subcutaneous ureteral bypass devices. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Advances in the prevention and management of central-line-associated bloodstream infections: The role of chelator-based catheter locks. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Ethanol/trisodium citrate for hemodialysis catheter lock. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A trial of topical prednisolone acetate before intravitreal triamcinolone acetonide decreases intraocular pressure spikes. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Preservative efficacy in cefuroxime and ceftazidime eye drop formulations. [2019]

8. India pubmed.ncbi.nlm.nih.gov

Effect of preservative, antioxidant and viscolizing agents on in vitro transcorneal permeation of ketorolac tromethamine. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Optimization of cosolvent concentration and excipient composition in a topical corticosteroid solution. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Studies on Surfactants, Cosurfactants, and Oils for Prospective Use in Formulation of Ketorolac Tromethamine Ophthalmic Nanoemulsions. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in orthopedic prosthetic surgery. [2022]

12. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Postoperative Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Prospective Randomized Controlled Study. [2021]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

Is Intraoperative Use of QuikClot Combat Gauze Effective for Hemostasis after Total Knee Arthroplasty? [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Comparison of Floseal® and Tranexamic Acid for Bleeding Control after Total Knee Arthroplasty: a Prospective Randomized Study. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intra-articular versus intravenous tranexamic acid in reducing perioperative blood loss in total knee arthroplasty: a prospective randomized double-blind equivalence trial. [2022]