CLiCK in the Critical Care Unit

Study Overview
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Brief Summary
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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.

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

Conditions
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Central Venous Catheter Thrombosis, Central Venous Catheter Related Bloodstream Infection, Catheter Complications, Catheter Blockage, Catheter Dysfunction, Central Line-associated Bloodstream Infection (CLABSI), Catheter, Catheter Infection

Intervention / Treatment
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* Device: 4% EDTA
* Device: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Multi-center, cluster-randomized, double-blinded, crossover study.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ethylenediaminetetraaceticacid