CLiCK in the Critical Care Unit

Catheter Complications Clinical Trial

— CLiCK  

Official title:

Control of Line Complications With KiteLock (CLiCK) in the Critical Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04548713
• Other study ID #: 0001
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Fraser Health
• Contact: Marlena Ornowska
• Phone: 2363326575
• Email: mornowsk[@]sfu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1524
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheter
• Catheter Blockage
• Catheter Complications
• Catheter Dysfunction
• Catheter Infection
• Central Line-associated Bloodstream Infection (CLABSI)
• Central Venous Catheter Related Bloodstream Infection
• Central Venous Catheter Thrombosis
• Communicable Diseases
• Infections
• Sepsis
• Thrombosis
• Upper Extremity Deep Vein Thrombosis

Intervention

Device:
• 4% EDTA
Sterile Catheter Lock Solution
• Saline
Saline Lock Solution

Locations

Country	Name	City	State
Canada	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

Sponsors (3)

Lead Sponsor	Collaborator
Fraser Health	Center for Health Evaluation & Outcome Services, SterileCare Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgroup analysis	Those with their CVAD in place for 7 days or more will be analyzed in a separate subgroup for primary and secondary outcomes	From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months
Primary	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.	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	Incidence rate of confirmed/suspected CLABSI	Confirmed diagnosis of CLABSI as diagnosed by the patients healthcare team and on the patient chart.	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	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.	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	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.	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	Direct cost related to alteplase use for catheter occlusion	This outcome will be evaluated based on economical analysis.	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
Secondary	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.	From date of randomization until the date of ICU discharge, patient death death, or through study completion, an average of 9 months
Secondary	Incidence rate of catheter colonization	Confirmed occurrence of catheter colonization as noted by the patients healthcare team and on the patient chart.	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	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.	From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months