Sepsis
Conditions
Brief summary
This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.
Interventions
OTHERProcalcitonin guided treatment
Patients who will be randomized to arm will receive antibiotics therapy based on procalcitonin measurement on day 1, 3, 5, 7, 9, 11 and 13.
OTHERConventional treatment
Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.
Sponsors
National Evidence-based healthcare Collaborating Agency (NECA)
Asan Medical Center
Samsung Medical Center
Severance Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients with suspicious or confirmed sepsis at admission or during stay in ICU * Patients with antibiotic duration of less than 48 hours before enrollment
Exclusion criteria
* Age less than or equal to 18 years * Known pregnancy * Specific infections for which long-term antibiotic treatment for 3 weeks more is strongly recommended: infective endocarditis, empyema, osteomyelitis et al. * severe immunocompromised patients : HIV infected patients (CD4 count \< 200 cells/mm3), Neutropenia (ANC count \< 500/mm3) * Presence of do-not-resuscitate order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of antibiotic treatment | up to 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response to treatment for infection | up to 28 days | success vs failure vs relapse after treatment |
| In ICU mortality | up to 28 days | — |
| All cause mortality | up to 28 days | — |
| In hospital mortality | up to 90 days | — |
Countries
South Korea
Outcome results
None listed