Sepsis
Conditions
Brief summary
Incidence of thrombocytopenia. Thrombopenia will be considered to be a platelet count below 75% of the patient's baseline value, at any time during the follow-up period.
Detailed description
Recurrence rate (relapses and reinfections) up to day 28: Recurrence is defined as the reappearance of symptoms of infection together with a positive culture for the same microorganism isolated in the initial culture in a patient with clinical cure at the cure visit. Reinfection is defined in a similar way, but with isolation of a different strain from the initial one., Mortality: mortality from all causes will be evaluated at 14 and 28 days., Changes in the SOFA scale: evolution of the daily values in the SOFA scale., Duration of admission to the critical care unit: number of days from admission to the critical care unit until being discharged from the unit., Days free from treatment with vasopressor agents: number of days that the patient avoided receiving vasopressor agents., Days free from mechanical ventilation: number of days that the patient avoided mechanical ventilation., Renal Replacement Therapy Free Days: Number of days the patient avoided renal replacement therapy., Days free of extracorporeal therapy: number of days that the patient avoided the use of extracorporeal membrane oxygenation., Percentage of patients in therapeutic range: the percentage of patients in therapeutic range will be evaluated, 2-7 mg/L, Percentage of patients achieving the target PK/PD parameter: the percentage of patients achieving the target PK/PD parameter of AUC0 →24h/MIC ≥100 and %T>MIC will be evaluated. When microbiological culture and its corresponding MIC are not available, the ECOFF value defined by EUCAST will be used.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of thrombocytopenia. Thrombopenia will be considered to be a platelet count below 75% of the patient's baseline value, at any time during the follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate (relapses and reinfections) up to day 28: Recurrence is defined as the reappearance of symptoms of infection together with a positive culture for the same microorganism isolated in the initial culture in a patient with clinical cure at the cure visit. Reinfection is defined in a similar way, but with isolation of a different strain from the initial one., Mortality: mortality from all causes will be evaluated at 14 and 28 days., Changes in the SOFA scale: evolution of the daily values in the SOFA scale., Duration of admission to the critical care unit: number of days from admission to the critical care unit until being discharged from the unit., Days free from treatment with vasopressor agents: number of days that the patient avoided receiving vasopressor agents., Days free from mechanical ventilation: number of days that the patient avoided mechanical ventilation., Renal Replacement Therapy Free Days: Number of days the patient avoided renal replacement therapy., Days | — |
Countries
Spain