CLiCK in the Critical Care Unit (CLiCK)

February 26, 2025 updated by: Steve Reynolds, Fraser Health

Control of Line Complications with KiteLock (CLiCK) in the Critical Care Unit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1449

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 2X6
        • Burnaby Hospital
      • Nanaimo, British Columbia, Canada
        • Nanaimo Regional General Hospital
      • New Westminster, British Columbia, Canada
        • Royal Columbian Hospital
      • Surrey, British Columbia, Canada
        • Surrey Memoral Hospital
      • Victoria, British Columbia, Canada
        • Royal Jubilee Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • St. Boniface Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • >18 years of age ICU/HAU Admission
  • Presence of a central venous catheter requiring locking. This includes CVCs, IVADs, dialysis lines, and PICC lines.

Exclusion Criteria:

  • Known or tested sensitivity to EDTA or edetate
  • Confirmed or suspected pregnancy
  • Patients who decline receiving blood products
  • Physician, patient, or temporary substitute decision maker (TSDM) declines
  • Currently enrolled in any other research study that may confound primary outcome measures. Co-enrollment in multiple studies will be considered on an individual basis
  • Patients who were previously enrolled in the study. Patients who were enrolled in the first period are not eligible for (re-)enrolment in the second period, and patients who are enrolled in the study and transferred to another participating hospital are not eligible for (re-)enrollment at the receiving hospital. Patients who had been discharged from the unit to another hospital ward and are re-admitted to the critical care unit are no eligible for re-enrollment into the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4% EDTA CVC Lock
Patients in this group will be given 4% EDTA as their CVC locking solution.
Device: 4% EDTA
Sterile Catheter Lock Solution
Other Names:
  • KiteLock 4% Sterile Catheter Lock Solution
Active Comparator: Standard of Care Saline CVC Lock
Patients in this group will be given standard of care saline as their CVC locking solution.
Device: Saline
Saline Lock Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures
Time Frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months.
incidence rate of the following: catheter obstruction requiring Alteplase, central-line associated bloodstream infection (CLABSI), or CVC replacement due to occlusion.
From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of confirmed/suspected CLABSI
Time Frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Confirmed diagnosis of CLABSI as diagnosed by the patients healthcare team and on the patient chart.
From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Incidence rate of catheter occlusion requiring removal
Time Frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Confirmed occurrence of occlusion requiring removal as noted by the patients healthcare team and on the patient chart.
From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Incidence rate of catheter obstruction requiring alteplase use
Time Frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Confirmed obstruction requiring alteplase use as noted by the patients healthcare team and on the patient chart.
From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Direct cost related to alteplase use for catheter occlusion
Time Frame: 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 outcome will be evaluated based on economical analysis.
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
Incidence rate of catheter-associated venous thrombosis
Time Frame: From date of randomization until the date of ICU discharge, patient death death, or through study completion, an average of 9 months
Confirmed occurrence of catheter-associated venous thrombosis as noted by the patients healthcare team and on the patient chart.
From date of randomization until the date of ICU discharge, patient death death, or through study completion, an average of 9 months
Incidence rate of catheter colonization
Time Frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Confirmed occurrence of catheter colonization as noted by the patients healthcare team and on the patient chart.
From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Classification of microbial species isolated from colonized catheters
Time Frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
A convenience sample of 15 colonized CVC's and 15 non-colonized CVC's (control) will be collected for further analysis as available.
From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup analysis
Time Frame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Those with their CVAD in place for 7 days or more will be analyzed in a separate subgroup for primary and secondary outcomes
From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fraser Health

Collaborators

SterileCare Inc.
Center for Health Evaluation & Outcome Services

Investigators

  • Principal Investigator: Steven Reynolds, MD, Fraser Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Actual)

October 10, 2024

Study Completion (Actual)

October 10, 2024

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001 (Researcher)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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