CLiCK in the Critical Care Unit

Fraser Health

Status: Enrolling

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

Treatments: Device: 4% EDTA; Device: Saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04548713

0001

Details and patient eligibility

About

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.

Enrollment: 1,524 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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1,524 participants in 2 patient groups

4% EDTA CVC Lock

Experimental group

Description:

Patients in this group will be given 4% EDTA as their CVC locking solution.

Treatment:

Device: 4% EDTA

Standard of Care Saline CVC Lock

Active Comparator group

Description:

Patients in this group will be given standard of care saline as their CVC locking solution.

Treatment:

Device: Saline