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CLiCK in the Critical Care Unit

Central Line-associated Bloodstream Infection (CLABSI) | Central Venous Catheter Thrombosis | Catheter...

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    19 and up

Participation 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.

Study Location

Surrey Memoral Hospital
Surrey Memoral Hospital
Surrey, British Columbia
Canada

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Royal Columbian Hospital
Royal Columbian Hospital
New Westminster, British Columbia
Canada

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Burnaby Hospital
Burnaby Hospital
Burnaby, British Columbia
Canada

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Primary Contact

Siti Rahmaputri

Royal Jubilee Hospital
Royal Jubilee Hospital
Victoria, British Columbia
Canada

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Nanaimo Regional General Hospital
Nanaimo Regional General Hospital
Nanaimo, British Columbia
Canada

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St. Boniface Hospital
St. Boniface Hospital
Winnipeg, Manitoba
Canada

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Study Sponsored By
Fraser Health
Participants Required
More Information
Study ID: NCT04548713