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
Conditions
Keywords
Ethylenediaminetetraaceticacid
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.
Interventions
DEVICE4% EDTA
Sterile Catheter Lock Solution
DEVICESaline
Saline Lock Solution
Sponsors
SterileCare Inc.
Center for Health Evaluation & Outcome Services
Fraser Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multi-center, cluster-randomized, double-blinded, crossover study.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Composite Outcome of CVAD Complications Modifiable by Lock Procedures | 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 the following: catheter obstruction requiring Alteplase, central-line associated bloodstream infection (CLABSI), or CVC replacement due to occlusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Confirmed diagnosis of CLABSI as diagnosed by the patients healthcare team and on the patient chart. |
| 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 | Confirmed occurrence of occlusion requiring removal as noted by the patients healthcare team and on the patient chart. |
| 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 | Confirmed obstruction requiring alteplase use as noted by the patients healthcare team and on the patient chart. |
| 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 | Confirmed occurrence of catheter-associated venous thrombosis as noted by the patients healthcare team and on the patient chart. |
| Incidence rate of catheter colonization | From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months | Confirmed occurrence of catheter colonization as noted by the patients healthcare team and on the patient chart. |
| Classification of microbial species isolated from colonized catheters | From date of randomization until the date of catheter removal, ICU discharge, patient death death, or through study completion, an average of 9 months | A convenience sample of 15 colonized CVC's and 15 non-colonized CVC's (control) will be collected for further analysis as available. |
| 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 | This outcome will be evaluated based on economical analysis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | Those with their CVAD in place for 7 days or more will be analyzed in a separate subgroup for primary and secondary outcomes |
Countries
Canada
Outcome results
None listed