Sepsis
Conditions
Keywords
PCT
Brief summary
Procalcitonin (PCT) has been widely used in the diagnosis and treatment of bacterial infectious diseases in China. The investigators aim to establish an algorithm based on BRAHMS PCT (VIDAS PCT) for patients with severe infections or sepsis in the EICU to reduce antibiotic exposure and verify its validity in the reduction of antibiotic exposure, clinical outcomes and costs saving.
Detailed description
This is a multi-center prospective study that will establish 9 centers. Based on preliminary on-site assessments, the centers will be grouped into two arms (SOC group and PCT group) according to their capacity for daily monitoring of PCT. Each center will enroll EICU patients with severe infections or sepsis who meet the inclusion and exclusion criteria. A total of 800 patients will be enrolled, with 400 in the PCT group and 400 in the SOC group. In the PCT group, clinicians will prescribe PCT tests every day for enrolled patients, with assigning a dedicated person monitoring the daily PCT results. Once the PCT \<0.5 ng/ml or ΔPCT (drop from the peak value) \>80%, the clinicians will receive a notification and will strictly adhere to guidelines and PCT values to adjust antibiotic prescriptions. The SOC group will not have any intervention regarding PCT prescriptions and antibiotic adjustments. The clinicians in the SOC group will prescribe PCT at routine frequency (usually once every 2-3 days or even longer) and adjust or discontinue antibiotics according to guidelines and their experiences. The primary and secondary endpoints will be evaluated in both groups. The primary endpoint is the total duration of antibiotic use. The secondary endpoints are the length of EICU stay and the total length of hospital stay.
Interventions
DEVICEPCT detection
Clinicians will prescribe PCT tests every day for enrolled patients, with assigning a dedicated person monitoring the daily PCT results. Once the PCT \<0.5 ng/ml or ΔPCT (drop from the peak value) \>80%, the clinicians will receive a notification and will strictly adhere to guidelines and PCT values to adjust antibiotic prescriptions.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≥18 * Suspected or confirmed bacterial patients * Stay EICU more than 3 days
Exclusion criteria
* age under 18 years; * PCT concentration throughout the entire hospitalization less than 0.5 ng/ml ; * known pregnancy; expected stay in the EICU less than 3 days; * bone-marrow transplant or chemotherapy-induced neutropenia (\<500 neutrophils per mL); * infections for which long-term antibiotic treatment is strongly recommended (ie, infective endocarditis, osteoarticular infections, anterior mediastinitis after cardiac surgery, hepatic or cerebral abscesses, chronic prostatitis, or infection with Mycobacterium tuberculosis, Pneumocystis jirovecii, or Toxoplasma gondii); * poor chance of survival, defined as a simplified acute physiology score (SAPS II) of more than 65 points at screening; and do-not-resuscitate orders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total duration of antibiotics use | From the day the patient was admitted to the EICU until the patient left the EICU, calculate how many days were antibiotics used. |
Secondary
| Measure | Time frame |
|---|---|
| Total length of hospital stay (calculated in days) | The calculation starts from the first day the patient is admitted to the EICU and extends to the day the patient is discharged (including the possibility of the patient being transferred from the EICU to other departments). |
Countries
China
Outcome results
None listed