Bacteremia
Conditions
Keywords
ethanol, lock therapy, vascular access, central venous catheter, sepsis
Brief summary
Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this study is to determine the efficacy of instilled ethanol (ethanol lock therapy) versus instilled antibiotics (antibiotic lock therapy) to save long-term venous device when infected, preventing their removal.
Interventions
DRUGEthanol-lock therapy
Daily ethanol-lock with 70% ethanol instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.
DRUGAntibiotic-lock
Daily antibiotic-lock according to 2009 IDSA Guidelines,instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: \>1 year and 10 Kgs * Long-term vascular device in place at least for 7 days * Catheter-related infection (at least presumed) * Will to save the infected device (expected high risk access)
Exclusion criteria
* Known ethanol-allergy * Known antabuse-like drugs in use * Religious refusal * S.aureus or Candida spp. as main pathogens (except in the unusual and documented scenarios when replacement of vascular access device proved to be very difficult) * Tract or pocket infection * Complicated infection (septic shock, infectious thrombosis, osteomyelitis, endocarditis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of saved devices | 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability | 60 days | Major adverse event (stop protocol): anaphylaxis, antabuse-like reaction, device damage, severe dysphoric reaction. Minor adverse events (do not stop protocol): nausea, vomiting, headache, dizziness. |
| Number of patients with proper parenteral therapy | 7 days | Verified by an Infectious Diseases Specialist |
| Ratio of saved devices | 15-30-60 days | — |
| Time for next bacteriemic episode | 30 days after the end of lock | — |
Countries
Italy
Contacts
Primary ContactMichele Pagani, MD
Backup ContactAndrea Bottazzi, MD
Outcome results
None listed