Catheter-related Bloodstream Infection, Central Line-associated Bloodstream Infection (CLABSI)
Conditions
Keywords
Central Line-associated Bloodstream Infection, Catheter-related Bloodstream Infection, Vancomycin, Critical Care, Bloodstream Infection
Brief summary
Randomized controlled trial of the effect of a single-dose intravenous Vancomycin after catheter replacement for suspected central line-associated bloodstream infection on resolution of infection in critically ill patients.
Detailed description
Patients on the local intensive care unit with suspicion of central line-associated bloodstream infection will be randomized to standard of care consisting of catheter replacement and blood and catheter tip cultures and to standard of care plus a single-dose vancomycin. The effect of the intervention on resolution of humoral inflammation and negativity of blood cultures will be assessed after 48 and 96 hours.
Interventions
DRUGVancomycin
The investigational drug vancomycin is administered intravenously through a newly inserted peripheral or central venous catheter directly after removal of the 'old' catheters. The investigational drug is administered with a volume of 500ml normal saline (NaCl 0.9%) with a rate of maximal 1g per hour.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Suspected central line-associated bloodstram infection defined as: * Catheterization with a non-tunneled CVC and * Clinical signs of local catheter infection or any increase in humoral inflammatory markers (PCT, CRP, WBC) or elevated body temperature ≥ 38.3°C not otherwise explained. Baseline CRP at screening ≥ 100 mg/L
Exclusion criteria
* known positive blood cultures at the time of randomization * High risk situation warranting immediate empiric antibiotic therapy: * endovascular implant (prosthetic valve, pacemaker, vascular graft) * high-risk for endocarditis warranting endocarditis-prophylaxis * Septic shock * Catheter replacement not feasible or no further indication for central venous catheterization * Known hypersensitivity to vancomycin or any component of the formulation. * Administration of Vancomycin, Teicoplanin, Daptomycin or Linezolid \<48 hours before enrolment. * Enrolment in another clinical study * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of infection | 96 hours after catheter replacement | Composite endpoint of absolute reduction of C-reactive protein and negativity of blood culture results at 48 and 96 hours (combinated with augmented binary method) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of IL-6 | 48 hours and 96 hours after catheter replacement | Absolute reduction of IL-6 (ng/L) in plasma |
| 28-day survival | 28 days | Survival after a follow-up of 28 days or until hospital discharge |
| ICU-free days at day 28 | 28 days | Cumulative days not admitted to the intensive care unit in patients alive at day 28 |
| Vasopressor-free days at day 28 | 28 days | Cumulative days of no vasopressor therapy in patients alive at day 28 |
| Invasive mechanical ventilation-free days at day 28 | 28 days | Cumulative days of no invasive mechanical ventilation in patients alive at day 28 |
| Antibiotic-free days at day 28 | 28 days | Cumulative days of no antibiotic therapy in patients alive at day 28 |
| Negativity of blood culture results | 48 hours and 96 hours after catheter replacement | Negativity of blood culture results after 48 hours, 96 hours and both |
| Reduction of C-reactive protein | 48 hours and 96 hours after catheter replacement | Absolute reduction of C-reactive protein (mg/dl) in plasma |
| Reduction of Procalcitonin | 48 hours and 96 hours after catheter replacement | Absolute reduction of Procalcitonin (mcg/L) in plasma |
| Reduction of white blood cell count | 48 hours and 96 hours after catheter replacement | Absolute reduction of white blood cell count (G/L) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood culture | from blood cultures drawn before replacement and at 48 and 96 hours | positivity of blood cultures |
| Vancomycin level in plasma | 24 hours after administration | Vancomycin level (mg/L) in plasma after 24 hours |
| Hypersensitivity reaction to Vancomycin | 6 hours after catheter replacement | Hypersensitivity reaction in the following 6 hours after vancomycin administration/catether replacement. Hypersensitivity reaction is defined as any new of the following symptoms: flushing, erythema, pruritus, pains or muscle spasms in the back or chest, dyspnea or hypotension. |
| Incidence of central line-associated bloodstream infections | from blood cultures drawn before replacement and at 48 and 96 hours | Definition according to the National Healthcare Safety Network (NHSN - CDC) Patient Safety Component Manual 2021 |
| Incidence of acute kidney injury | 28 days | Incidence of new or worsening acute kidney injury according to the definition and classification of the KDIGO 2012 guidelines |
Outcome results
None listed