CLiCK in the Critical Care Unit

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.

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

Interventions

DEVICE

4% EDTA

Sterile Catheter Lock Solution

DEVICE

Saline

Saline Lock Solution

Sponsors & Collaborators

• SterileCare Inc.

  collaborator INDUSTRY

• Center for Health Evaluation & Outcome Services

  collaborator UNKNOWN

• Fraser Health

  lead OTHER

Principal Investigators

• Steven Reynolds, MD · Fraser Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-22

Primary Completion

2024-10-10

Completion

2024-10-10

Countries

• Canada

Study Locations