Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04548713
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2020-09-03
Brief Title:
CLiCK in the Critical Care Unit
Sponsor:
Fraser Health
Organization:
Fraser Health
Study Overview
Official Title:
Control of Line Complications With KiteLock CLiCK in the Critical Care Unit
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLiCK
Brief 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 ICUs compared to the standard of care saline lock
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 ICUs compared to the standard of care saline lock
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None