- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03158493
Assessment of qSOFA in the Latin America Sepsis Institute Database
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
All hospitals in the Latin America Sepsis Institute network were invited to participate. This is a national based quality improvement initiative aiming to improve compliance with the sepsis bundles and mortality. The hospitals were instructed to include all patients that presented with the diagnosis of sepsis or septic shock in the emergency department (ED), wards or ICU. The diagnosis of sepsis was based on the previous criteria used by the network, which means presence of suspected infection and an infection-associated organ dysfunction. Organ dysfunction was defined by the presence of any of the following: systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg or fall in systolic blood pressure> 40 mmHg; creatinine> 2.0 mg / dl or diuresis less than 0.5 ml/kg/h in the last 2 hours, bilirubin> 2mg/dl, platelet count<100,000, lactate> 2 mmol/dl (or above the reference value), coagulopathy (RNI> 1.5 or APTT>60 sec), PaO2/FiO2 ratio <300 or recent or increased O2 need to maintain SpO2> 90. Suspected of infection was based on the clinical suspicious by the attending physician. All patients under end-of-life care and those previously included in the database in the same hospital admission were excluded.
The case managers were instructed to collect the 3 components of the qSOFA criteria, namely reduced level of consciousness, respiratory rate higher than 22 bpm and systolic blood pressure lower than 100 mmHg). In patients included from the ED, these components were checked at the time of triage. In patients in the wards or in the ICU, the 3 components were considered if presented any time in the 24 hours prior to the diagnosis of sepsis.
Outcomes Primary outcome was hospital mortality. Secondary endpoints included admission to ICU and length of ICU stay of more than 48 hours. A secondary composite outcome was hospital mortality plus ICU length of stay higher than two days (for those admitted to the ICU).
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Suspected source of infection
Presence of any of the following organ dysfunction
- Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg or fall in systolic blood pressure> 40 mmHg.
- Creatinine> 2.0 mg / dl or diuresis less than 0.5 ml/kg/h in the last 2 hours OR
- Bilirubin> 2mg/dl,
- Platelet count<100,000,
- Lactate> 2 mmol/dl (or above the reference value),
- Coagulopathy (RNI> 1.5 or APTT>60 sec),
- PaO2/FiO2 ratio <300 or recent or increased O2 need to maintain SpO2> 90
Exclusion Criteria:
- End of life care
- Previous sepsis episode in the same hospital admission
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hospital mortality
Tidsramme: From date of inclusion through study completion, assessed up to 100 months
|
mortality at hospital
|
From date of inclusion through study completion, assessed up to 100 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
admission to ICU in the first 24 hours of the diagnosis of sepsis
Tidsramme: From date of inclusion until 24 hours after the diagnosis of sepsis, assessed up to 24 hours after the diagnosis of sepsis
|
number of patients who were admitted in the intensive care unit
|
From date of inclusion until 24 hours after the diagnosis of sepsis, assessed up to 24 hours after the diagnosis of sepsis
|
length of ICU stay of more than 48 hours
Tidsramme: From date of inclusion until 2 days after ICU admission
|
duration of ICU stay was greater than 2 days
|
From date of inclusion until 2 days after ICU admission
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Flavia R Machado, MD, Federal University of São Paulo
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 00691812.3.0000.5505
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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