Assessment of qSOFA in the Latin America Sepsis Institute Database

Sepsis Clinical Trial

Official title:

Assessment of qSOFA in the Latin America Sepsis Institute Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158493
• Other study ID #: 00691812.3.0000.5505
• Status: Completed
• Phase: N/A
• First received: May 15, 2017
• Last updated: May 22, 2017
• Start date: May 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Recently, the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM) have published new definitions of sepsis, known as Sepsis 3, based on a fairly robust analysis of large, essentially American, databases. In addition to the new definition, a new screening score was suggested, named quickSOFA (qSOFA). This score is positive if two of three variables are present: respiratory rate higher than 22 ipm, reduced level of consciousness and systolic blood pressure lower than 100 mmHg. Although the receiver operator characteristics (ROC) curves suggest an adequate predictive validity for the new score, a lot of controversy around its sensitivity as a screening tool mainly in settings with high mortality rates. Current national Brazilian data show that sepsis mortality in our country, especially in public hospitals from the Unified Health System (SUS), is very high and well above world mortality. The impact of using the qSOFA in these settings is not known. In this context, the present study aims to evaluate the potential impact of using qSOFA as a screening tool in Brazilian private and public institutions. The hypothesis is that the use of qSOFA as a screening tool will have a low sensitivity. As a consequence, patients with the diagnosis of sepsis, with organ dysfunction, will not be detected by this tool. The hypothesis was also that those patients with a qSOFA negative will have a high mortality rate, mainly in Brazilian public hospitals.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8435
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Latin America Sepsis Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital mortality	mortality at hospital	From date of inclusion through study completion, assessed up to 100 months
Secondary	admission to ICU in the first 24 hours of 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
Secondary	length of ICU stay of more than 48 hours	duration of ICU stay was greater than 2 days	From date of inclusion until 2 days after ICU admission