Trials / Completed
CompletedNCT04548713
CLiCK in the Critical Care Unit
Control of Line Complications With KiteLock (CLiCK) in the Critical Care Unit
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,449 (actual)
- Sponsor
- Fraser Health · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | 4% EDTA | Sterile Catheter Lock Solution |
| DEVICE | Saline | Saline Lock Solution |
Timeline
- Start date
- 2022-03-22
- Primary completion
- 2024-10-10
- Completion
- 2024-10-10
- First posted
- 2020-09-14
- Last updated
- 2025-02-28
Locations
6 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT04548713. Inclusion in this directory is not an endorsement.