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Antimicrobial, Anti-biofilm, and Anti-thrombotic Solution

4% EDTA for Catheter-Associated Infections (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

CLiCK Trial 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.Check my eligibility

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.See study design

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.

CLiCK Trial Timeline

Screening ~ 3 weeks3 visits

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures

Secondary outcome measures

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 outcome measures

Subgroup analysis

CLiCK 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fraser HealthLead Sponsor

45 Previous Clinical Trials

705,966 Total Patients Enrolled

SterileCare Inc.Industry Sponsor

2 Previous Clinical Trials

174 Total Patients Enrolled

Center for Health Evaluation & Outcome ServicesUNKNOWN

Media Library

Catheter-Associated Infections Clinical Trial 2023: KiteLock Sterile Locking Solution Highlights & Side Effects. Trial Name: NCT04548713 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for participants in this experiment?

"Affirmative. The clinical trial's data on clinicaltrials.gov states that recruitment is still in progress, with the initial posting having taken place March 22nd 2022 and the last update occurring July 5th 2021. A total of 1690 participants need to be recruited from across five sites."

Answered by AI

How many research locations are enacting this experiment?

"The ongoing medical study is located in 5 diverse locations, including Nanaimo Regional General Hospital, Royal Columbian Hospital and St. Boniface Hospital; with two additional sites also offering the intervention."

Answered by AI

What is the cap for enrollment in this research project?

"Correct. Information available on clinicaltrials.gov affirms that this trial, which was initiated on March 22nd 2022, is actively enrolling participants. A total of 1690 individuals need to be recruited from 5 different sites."

Answered by AI

What objectives are being pursued in this research endeavor?

"This clinical trial aims to measure the Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures within a 16 months timeframe, starting from randomization. The secondary outcomes are Incidence rate of catheter-associated venous thrombosis, Incidence of catheter obstruction requiring alteplase use., and Incidence rate of catheter colonization."

Answered by AI

Recent research and studies

TrialsJournal

Control of Line Complications with Kitelock (click) in the Critical Care Unit: Study Protocol for a Multi-center, Cluster-randomized, Double-blinded, Crossover Trial Investigating the Effect of a Novel Locking Fluid on Central Line Complications in the Critical Care Population

Ornowska, Marlena, Hubert Wong, Yongdong Ouyang, Anish Mitra, Aaron White, Sue Willems, Jessica Wittmann, and Steven Reynolds. 2022. “Control of Line Complications with Kitelock (click) in the Critical Care Unit: Study Protocol for a Multi-center, Cluster-randomized, Double-blinded, Crossover Trial Investigating the Effect of a Novel Locking Fluid on Central Line Complications in the Critical Care Population”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06671-5.

clinicaltrials.govStudy

CLiCK in the Critical Care Unit

Steve Reynolds 2022. "CLiCK in the Critical Care Unit". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04548713.

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