CLiCK in the Critical Care Unit

Fraser Health1,449 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,449

Conditions

Central Venous Catheter Thrombosis

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (6)

Burnaby Hospital

Burnaby, British Columbia, Canada

Nanaimo Regional General Hospital

Nanaimo, British Columbia, Canada

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Surrey Memoral Hospital

Surrey, British Columbia, Canada

Royal Jubilee Hospital

Victoria, British Columbia, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

Incidence rate of confirmed/suspected CLABSI

Confirmed diagnosis of CLABSI as diagnosed by the patients healthcare team and on the patient chart.

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 catheter occlusion requiring removal

Confirmed occurrence of occlusion requiring removal as noted by the patients healthcare team and on the patient chart.

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 catheter obstruction requiring alteplase use

Confirmed obstruction requiring alteplase use as noted by the patients healthcare team and on the patient chart.

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

Direct cost related to alteplase use for catheter occlusion

This outcome will be evaluated based on economical analysis.

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

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.

Time frame: 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.

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

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.

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

CLiCK in the Critical Care Unit

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes