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Antimicrobial, Anti-biofilm, and Anti-thrombotic Solution

Catheter Locking Solution for Catheter Complications (CLiCK Trial)

N/A
Recruiting
Led By Steven Reynolds, MD
Research Sponsored by Fraser Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study from date of randomization until the date of catheter removal, icu discharge, patient death death, or through study completion, an average of 9 months, an average of 16 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a new type of catheter locking solution can help reduce complications in patients with central venous access devices.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of using the EDTA lock solution may include allergic reactions due to sensitivity to EDTA. However, specific side effects are not detailed here and would be monitored during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study from date of randomization until the date of catheter removal, icu discharge, patient death death, or through study completion, an average of 9 months, an average of 16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study from date of randomization until the date of catheter removal, icu discharge, patient death death, or through study completion, an average of 9 months, an average of 16 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures
Secondary study objectives
Classification of microbial species isolated from colonized catheters
Direct cost related to alteplase use for catheter occlusion
Incidence rate of catheter colonization
+4 more
Other study objectives
Subgroup analysis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 4% EDTA CVC LockExperimental Treatment1 Intervention
Patients in this group will be given 4% EDTA as their CVC locking solution.
Group II: Standard of Care Saline CVC LockActive Control1 Intervention
Patients in this group will be given standard of care saline as their CVC locking solution.

Find a Location

Who is running the clinical trial?

Fraser HealthLead Sponsor
47 Previous Clinical Trials
706,088 Total Patients Enrolled
SterileCare Inc.Industry Sponsor
2 Previous Clinical Trials
174 Total Patients Enrolled
Center for Health Evaluation & Outcome ServicesUNKNOWN
Steven Reynolds, MDPrincipal InvestigatorFraser Health
3 Previous Clinical Trials
62 Total Patients Enrolled

Media Library

Catheter-Associated Infections Clinical Trial 2023: KiteLock Sterile Locking Solution Highlights & Side Effects. Trial Name: NCT04548713 — N/A
~416 spots leftby Dec 2025
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