CLiCK in the Critical Care Unit (CLiCK)

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.

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

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.

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

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

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

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

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

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

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.

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.