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| Name | Class |
|---|---|
| SterileCare Inc. | INDUSTRY |
| Center for Health Evaluation & Outcome Services | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4% EDTA CVC Lock | Experimental | Patients in this group will be given 4% EDTA as their CVC locking solution. |
|
| Standard of Care Saline CVC Lock | Active Comparator | Patients in this group will be given standard of care saline as their CVC locking solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4% EDTA | Device | Sterile Catheter Lock Solution |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence rate of catheter occlusion requiring removal |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Reynolds, MD | Fraser Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burnaby Hospital | Burnaby | British Columbia | V5G 2X6 | Canada | ||
| Nanaimo Regional General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42150112 | Derived | Ornowska M, Wittmann J, Blitz S, Wong H, Vazquez-Grande G, Mitra AR, Jang W, Wood G, Ovakim D, Forrest D, Rohrs E, Reynolds S. 4% Tetrasodium EDTA to Prevent Central Venous Access Device-Associated Complications: A Randomized Clinical Trial. JAMA. 2026 May 18:e266025. doi: 10.1001/jama.2026.6025. Online ahead of print. | |
| 36042488 |
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Multi-center, cluster-randomized, double-blinded, crossover study.
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| Saline | Device | Saline Lock Solution |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| ID | Term |
|---|---|
| D056824 | Upper Extremity Deep Vein Thrombosis |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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