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

Health Research BC is providing match funds for this project, which is funded by the CANTRAIN-CTTP & Michael Smith Health Research BC Doctoral Studentship 2023 Award Program.  

Supported through the CANHealth Network, MITACS Accelerate, the Royal Columbian Hospital Foundation, and SterileCare Inc., CLiCK is a pan-Canadian clinical trial that investigates whether locking Central Venous Access Devices (CVADs) with 4% EDTA fluid is effective in reducing CVAD-associated complications in adult critical care patients.  

Dr. Steven Reynolds, ICU Physician at Royal Columbian Hospital, Professor at Simon Fraser University, and Executive Lead at the Advancing Innovation in Medicine Institute, is the Senior Investigator of the trial, along site Drs. Anish Mitra, Gordon Wood, Daniel Ovakim, David Forrest, Mark James, Gloria Vazquez-Grande, and Wesley Jang as Site Principal Investigators. Marlena Ornowska is the Doctoral Student working on this project.  

A CVAD is a thin tube that is inserted into one of the large, central veins of a patient. This tube allows doctors and nurses to deliver medication, fluids, blood, or nutrients directly into the bloodstream. During breaks between medications or infusions, nurses fill the inside of the tube with salt water or citrate to keep it open and ready for the next use. This is called ‘locking’ the CVAD.  

Because a CVAD is a foreign object introduced into the body, patients may develop complications such as infection and blood clots. These may be prevented by using a locking fluid has anti-bacterial and anti-thrombotic properties. One example of this type of fluid is called 4% EDTA. Our trial is investigating whether patients whose CVADs are ‘locked’ with 4% EDTA experience fewer complications than those who have their CVADs locked with salt water or citrate. This project will help us understand and create safer CVAD care in this vulnerable patient population.  

End of Award Update – December 2024

Results

The study is currently ongoing, but has hit major milestones this year. We have finally completed data collection at all six of our participating sites as of September 2024. This has been a long journey, as our first patient was enrolled in March 2022. In total, we enrolled over 1400 patients over two and a half years. To our knowledge, this study is one of the largest CVAD locking trials completed in the critical care population to date. We have also completed monitoring of data at all of our sites as of November of this year. The subject matter of our research has also attracted international attention, with an invited presentation at the World Congress on Vascular Access held in April 2024 in Prague.  

Impact

Completing this clinical trial has resulted in research collaboration between six hospitals in British Columbia and Manitoba (Royal Columbian Hospital, Surrey Memorial Hospital, Burnaby Hospital, Royal Jubilee Hospital, Nanaimo Regional General Hospital, and St. Boniface Hospital), and introduced a new technology into the critical care units of each of these centers.  

Additionally, through the Health Innovation Pathway Program supported by the BC Ministry of Health, a preliminary health economic analysis model for 4% EDTA was constructed by Institute of Health Economics in Edmonton, Alberta. Inputting our final results into this model will quantify the financial impact of adopting 4% EDTA into the standard of care, taking into account cost of 4% EDTA and any savings associated with a reduction in CVAD complications. The model is also able to compare this to the costs of using saline and citrate as locking fluids (the current standard of care).   

Potential Influence

Should the intervention prove successful, it has the potential to decrease incidence of catheter-related bloodstream infection, occlusion, and catheter-related thrombosis in the critical care population, as well as costs related to treating these complications. Results of the study will also be disseminated to Fraser Health Innovation, Vascular Access, and Procurement teams, for consideration of adoption and purchase by the health authority.   

Next Steps

Our next steps include data cleaning, analysis of data, as well as dissemination of results. We plan to disseminate results to research and clinical staff at each of our participating sites, as well as key decision makers within the Fraser Health Authority, as mentioned above. We will also apply to present at conferences related to critical care and vascular access, and publish results in a peer-reviewed journal.  

Useful Links

Three publications relevant to our research question:  

1. Observational study at Royal Columbian Hospital, through which we gathered information about baseline rates of relevant CVAD complications that informed the protocol of our clinical study: https://pubmed.ncbi.nlm.nih.gov/36306232/ 
2. Systematic review of locking fluid trials in the critical care population performed to date: https://pubmed.ncbi.nlm.nih.gov/37824460/ 
3. Study protocol published in TRIALS journal: https://pubmed.ncbi.nlm.nih.gov/36042488/