CLiCK in the Critical Care Unit

NCT ID: NCT04548713

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2024-10-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

4% EDTA CVC Lock

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

Group Type: EXPERIMENTAL

4% EDTA

Intervention Type: DEVICE

Sterile Catheter Lock Solution

Standard of Care Saline CVC Lock

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

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: DEVICE

Saline Lock Solution

Interventions

4% EDTA

Sterile Catheter Lock Solution

Intervention Type: DEVICE

Saline

Saline Lock Solution

Intervention Type: DEVICE

Other Intervention Names

KiteLock 4% Sterile Catheter Lock Solution

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SterileCare Inc.

INDUSTRY

Sponsor Role: collaborator

Center for Health Evaluation & Outcome Services

UNKNOWN

Sponsor Role: collaborator

Fraser Health

OTHER

Sponsor Role: lead

Responsible Party

Steve Reynolds

Critical Care Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

Fraser Health

Locations

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, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36042488 (View on PubMed)

Other Identifiers

0001

Identifier Type: -

Identifier Source: org_study_id