Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05172479 |
| Other study ID # |
ACH-2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 12, 2021 |
| Est. completion date |
September 11, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Aseer Central Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Early identification of a patient with infection who may develop sepsis is of utmost
importance. Unfortunately, this remains elusive because no single clinical measure or test
can reflect complex pathophysiological changes in patients with sepsis. However, multiple
clinical and laboratory parameters indicate impending sepsis and organ dysfunction. Screening
tools using these parameters can help identify the condition, such as SIRS, quick SOFA
(qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS). The
2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign
strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening
tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy
than SIRS and EWS (NEWS/NEWS2/MEWS).
Description:
Over the past decade, medical advances in sepsis continued to focus on sepsis as a prevalent
condition that accounts for 10% of admissions to intensive care units (ICUs) and is
associated with a 10-20% in-hospital mortality rate. Standardised protocols and physician
awareness have significantly improved survival, but mortality rates remain between 20% and
36%, with ~270,000 deaths annually in the United States. However, of patients with sepsis,
80% are treated in an emergency department (ED), and the remainder develops sepsis during
hospitalisation with other conditions. In 2016, the Society of Critical Care
Medicine/European Society of Intensive Care Medicine (SCCM/ESICM) task force redefined sepsis
based on organ dysfunction and mortality prediction. Sepsis now is defined as
life-threatening organ dysfunction caused by dysregulated host response to infection. This
definition emphasises the complexity of the disease that cannot be explained by infection or
body response to it. Acute change in Sequential Organ Failure Assessment (SOFA) score ≥2
indicates sepsis-related organ dysfunction, a predictor of excess in-hospital mortality.
Systemic Inflammatory Response Syndrome (SIRS) and "severe sepsis" terms were omitted from
the most recent definition. SIRS has been criticised for its poor specificity, while "severe
sepsis" may underestimate sepsis's seriousness. A subset of patients may develop septic shock
with underlying profound organ dysfunction and excess mortality. Clinically, septic shock is
defined as persistent hypotension requiring vasopressors to maintain mean arterial pressure
(MAP) ≥ 65 mm Hg and serum lactate level ≥ 2 mmol/L (18 mg/dL) despite adequate volume
resuscitation. Early identification of a patient with infection who may develop sepsis is of
utmost importance. Unfortunately, this remains elusive because no single clinical measure or
test can reflect complex pathophysiological changes in patients with sepsis. However,
multiple clinical and laboratory parameters indicate impending sepsis and organ dysfunction.
Screening tools using these parameters can help identify the condition, such as SIRS, quick
SOFA (qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS).
The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis
Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single
screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic
accuracy than SIRS and EWS (NEWS/NEWS2/MEWS).
