Catheter Locking Solution for Catheter Complications

(CLiCK Trial)

No longer recruiting at 5 trial locations

Overseen By Sue Willems, BSc (N), CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fraser Health

Disqualifiers: Sensitivity to EDTA, Pregnancy, Blood product refusal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new catheter locking solution called KiteLock Sterile Locking Solution, which might reduce complications like infections and blockages in patients with central venous catheters (tubes inserted into a large vein). It compares this new solution to the standard saline solution to determine if it performs better in preventing issues. The trial seeks ICU patients with a central venous catheter who do not have a known sensitivity to the solution. As an unphased trial, it offers patients the opportunity to contribute to important research that could enhance catheter care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this catheter locking solution is safe for use in patients?

Research has shown that a 4% tetrasodium EDTA solution, a type of salt, is safe for use in catheters. In previous studies, this solution reduced line problems by 50% compared to other common solutions like heparin, resulting in fewer blockages or infections in catheter lines.

Other studies have found that 4% EDTA helps keep catheters open and clean by preventing clots and fighting bacteria. Importantly, these studies suggest it is safe to use. Even when patients experienced difficulty drawing fluid from the catheter, flushing with 4% EDTA remained safe.

Overall, the evidence suggests that 4% EDTA is a well-tolerated and effective option for reducing catheter-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the KiteLock Sterile Locking Solution because it introduces a new approach to preventing catheter complications. Unlike the standard saline lock, which primarily acts to maintain catheter patency, KiteLock employs 4% EDTA as its active ingredient. EDTA not only helps in keeping the catheter open but also has the potential to reduce biofilm formation and bacterial growth due to its chelating properties. This dual action could make KiteLock a more effective solution for reducing catheter-related infections and complications.

What evidence suggests that the KiteLock Sterile Locking Solution could be an effective treatment for catheter complications?

This trial will compare the effectiveness of different catheter locking solutions. Research has shown that a 4% EDTA lock solution, which participants in one arm of this trial will receive, can effectively reduce catheter-related problems. One study found a 50% decrease in issues compared to other solutions. Specifically, patients using 4% EDTA experienced fewer blockages and infections. Another study reported a significant drop in bloodstream infections linked to central lines, making 4% EDTA a promising option for reducing risks associated with catheter use in intensive care. ^{1 2 3 6 7}

Who Is on the Research Team?

Steven Reynolds, MD

Principal Investigator

Fraser Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 in the ICU with a central venous catheter needing locking. It's not for those who refuse blood products, are sensitive to EDTA, pregnant, involved in other conflicting studies, or previously enrolled.

Inclusion Criteria

Presence of a central venous catheter requiring locking. This includes CVCs, IVADs, dialysis lines, and PICC lines.

Exclusion Criteria

You refuse to receive blood products.

Known or tested sensitivity to EDTA or edetate

Confirmed or suspected pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the standard saline lock or the experimental 4% EDTA lock solution

9 months

Regular monitoring visits throughout ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KiteLock Sterile Locking Solution

Trial Overview

The study tests if 4% EDTA solution (KiteLock) is better than normal saline as a lock solution to prevent infections and blockages in catheters used by ICU patients. It's a multi-center study comparing these two methods.

How Is the Trial Designed?

Group I: 4% EDTA CVC Lock Experimental Treatment 1 Intervention

Patients in this group will be given 4% EDTA as their CVC locking solution.

Group II: Standard of Care Saline CVC Lock Active Control 1 Intervention

Patients in this group will be given standard of care saline as their CVC locking solution.

Who Is Running the Clinical Trial?

Fraser Health

Lead Sponsor

Trials

49

Recruited

708,000+

SterileCare Inc.

Industry Sponsor

Trials

3

Recruited

1,600+

SterileCare Inc.

Collaborator

Trials

2

Recruited

1,500+

Center for Health Evaluation & Outcome Services

Collaborator

Trials

1

Recruited

1,400+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11216891/

A retrospective cohort study - PMC - PubMed Central

Intervention with 4% T-EDTA as a catheter lock solution resulted in a 50% reduction in line complications compared to baseline sample rates on heparin/ELT in a ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04559334

Compassionate-Use of 4% T-EDTA Lock Solution for ...

Since its first approval in Canada, the use of 4% T-EDTA lock solution has been associated with a significant decrease in both catheter occlusions and CLABSI ...

3.

aspenjournals.onlinelibrary.wiley.com

aspenjournals.onlinelibrary.wiley.com/doi/abs/10.1002/jpen.2644

Administration of 4% tetrasodium EDTA lock solution and ...

CVC complications were documented (repairs, occlusions, replacements, and CLABSIs). Complication rates on 4% T-EDTA were compared with baseline ...

4.

sterilecareinc.com

sterilecareinc.com/wp-content/uploads/2020/09/Hill-et.-al-JVA-2020.pdf

Efficacy of 4% tetrasodium ethylenediaminetetraacetic acid ...

Post intervention, 20 home parenteral nutrition patients experienced significant reduction in the central line-associated bloodstream infection rate (pre = ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2950456224000356

A comparison of catheter lock solutions and associated ...

Taurolidine and EDTA locks are similarly effective in preventing infections and equally likely to be associated with occlusion or breakage.

6.

journals.lww.com

journals.lww.com/journalofinfusionnursing/fulltext/2024/07000/implementing_a_4__edta_central_catheter_locking.7.aspx

Implementing a 4% EDTA Central Catheter Locking ...

In terms of safety and efficacy of flushing 4% EDTA, studies have indicated that it is safe to flush 4% EDTA when unable to withdraw.26 ,27 The existing body of ...

7.

trialx.com

trialx.com/clinical-trials/listings/222849/use-of-tetrasodium-edta-catheter-lock-solution-for-patients-on-htpn/

Use of Tetrasodium EDTA Catheter Lock Solution for ...

One recently developed solution, tetrasodium EDTA, aims to reduce both thrombosis and infection. This scientific review provides an overview of ...