Clinical trial NCT04548713: CLiCK in the Critical Care Unit
Official title: Control of Line Complications With KiteLock (CLiCK) in the Critical Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Ethylenediaminetetraaceticacid
Lead sponsor: Fraser Health
Sponsor class: OTHER
Collaborators: name: SterileCare Inc.
name: Center for Health Evaluation & Outcome Services
First posted: 2020-09-14
Enrollment: 1449
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multi-center, cluster-randomized, double-blinded, crossover study.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures
timeFrame: 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 outcomes:
measure: Incidence rate of confirmed/suspected CLABSI
timeFrame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
measure: Incidence rate of catheter occlusion requiring removal
timeFrame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
measure: Incidence rate of catheter obstruction requiring alteplase use
timeFrame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
measure: Direct cost related to alteplase use for catheter occlusion
timeFrame: 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
measure: Incidence rate of catheter-associated venous thrombosis
timeFrame: From date of randomization until the date of ICU discharge, patient death death, or through study completion, an average of 9 months
measure: Incidence rate of catheter colonization
timeFrame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
measure: Classification of microbial species isolated from colonized catheters
timeFrame: 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 outcomes:
measure: Subgroup analysis
timeFrame: From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Locations:
city: Burnaby
country: Canada
facility: Burnaby Hospital
state: British Columbia
city: Nanaimo
country: Canada
facility: Nanaimo Regional General Hospital
state: British Columbia
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memoral Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
Study officials:
affiliation: Fraser Health
name: Steven Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ornowska M, Wong H, Ouyang Y, Mitra A, White A, Willems S, Wittmann J, Reynolds S. 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. 2022 Aug 30;23(1):719. doi: 10.1186/s13063-022-06671-5.