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Completed

NCT Number: NCT04548713

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.

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Key information

Conditions

Central Venous Catheter Thrombosis Cardiovascular Diseases Catheter Catheter Blockage Catheter Complications Catheter Dysfunction Catheter Infection Central Line-associated Bloodstream Infection (CLABSI) Central Venous Catheter Related Bloodstream Infection Embolism and Thrombosis Thrombosis Upper Extremity Deep Vein Thrombosis Vascular Diseases Venous Thrombosis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burnaby Hospital, Burnaby, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4% EDTA

Device

Sterile Catheter Lock Solution

Other names: KiteLock 4% Sterile Catheter Lock Solution

Saline

Device

Saline Lock Solution

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fraser Health

Other

Collaborators

  • Center for Health Evaluation & Outcome Services
  • SterileCare Inc.

Registry information

Official study title

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

Acronym: CLiCK

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2020
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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