CLiCK in the Critical Care Unit

NCT04548713 | Completed DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 1,449
• Locations: 1 country
• Sites: 6

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 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

Keywords

Ethylenediaminetetraaceticacid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence rate of confirmed/suspected CLABSI

  From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months

• Incidence rate of catheter occlusion requiring removal

  From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months

• Incidence rate of catheter obstruction requiring alteplase use

  From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months

• Direct cost related to alteplase use for catheter occlusion

  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

• Incidence rate of catheter-associated venous thrombosis

  From date of randomization until the date of ICU discharge, patient death death, or through study completion, an average of 9 months

Other Outcomes (1)

• Subgroup analysis

  From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months

Study Arms (2)

4% EDTA CVC Lock

EXPERIMENTAL

Patients in this group will be given 4% EDTA as their CVC locking solution.

Device: 4% EDTA

Standard of Care Saline CVC Lock

ACTIVE COMPARATOR

Patients in this group will be given standard of care saline as their CVC locking solution.

Device: Saline

Interventions

4% EDTA DEVICE

Sterile Catheter Lock Solution

Also known as: KiteLock 4% Sterile Catheter Lock Solution

4% EDTA CVC Lock

Saline DEVICE

Saline Lock Solution

Standard of Care Saline CVC Lock

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age ICU/HAU Admission
• Presence of a central venous catheter requiring locking. This includes CVCs, IVADs, dialysis lines, and PICC lines.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fraser Health: lead
• SterileCare Inc.: collaborator
• Center for Health Evaluation & Outcome Services: collaborator

Study Sites (6)

Burnaby Hospital

Burnaby, British Columbia, V5G 2X6, Canada

Location

Nanaimo Regional General Hospital

Nanaimo, British Columbia, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Location

Surrey Memoral Hospital

Surrey, British Columbia, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Location

Related Publications (1)

• Ornowska M, Wong H, Ouyang Y, Mitra A, White A, Willems S, Wittmann J, Reynolds S. Control of Line Complications with KiteLock (CLiCK) in the critical care unit: study protocol for a multi-center, cluster-randomized, double-blinded, crossover trial investigating the effect of a novel locking fluid on central line complications in the critical care population. Trials. 2022 Aug 30;23(1):719. doi: 10.1186/s13063-022-06671-5.

  PMID: 36042488 DERIVED

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Steven Reynolds, MD

  Fraser Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical Care Physician

Model Details: Multi-center, cluster-randomized, double-blinded, crossover study.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 14, 2020
• Study Start: March 22, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)