Catheter Locking Solution for Catheter Complications

(CLiCK Trial)

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

1449 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADss are prone to complications such as infection, bacterial biofilm production, and catheter occlusion due to a thrombus. A CVAD is placed in up to 97% of patients in the intensive care unit, exposing this vulnerable population to risk of nosocomial infection and occlusion. Current standard of care involves use of normal saline (for CVCs and PICCs) or citrate (for hemodialysis catheters) as a catheter locking solution. CVAD complications remain a problem with current standard of care. 4% tetrasodium Ethylenediaminetetraacetic acid (EDTA) fluid (KiteLock Sterile Locking Solution) possesses antimicrobial, anti-biofilm, and anti-thrombotic properties and is approved by Health Canada as a catheter locking solution. As such, it may be superior CVC locking solution than the present normal saline or citrate lock. To our knowledge, the efficacy of an EDTA catheter locking solution has not yet been investigated in the intensive care patient population. Our team proposes to fill this knowledge gap by performing a multi-centre, cluster-randomized, crossover study evaluating the impact of KiteLock Sterile Locking Solution on a primary composite outcome of CLABSI, intraluminal occlusion, and alteplase use in the ICU of six ICU's compared to the standard of care saline lock.

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+