Thu Feb 08 2024

qSOFA combined with suPAR for early risk detection and guidance of antibiotic treatment in the emergency department: a randomized controlled trial

Background:

Sepsis guidelines suggest immediate start of resuscitation for patients with quick Sequential Organ
Failure Assessment (qSOFA) 2 or 3. However, the interpretation of qSOFA 1 remains controversial. We investigated
whether measurements of soluble urokinase plasminogen activator receptor (suPAR) may improve risk detection
when qSOFA is 1.

Methods: 

The study had two parts. At the first part, the combination of suPAR with qSOFA was analyzed in a prospective
cohort for early risk detection. At the second part, the double-blind, randomized controlled trial (RCT) SUPERIOR
evaluated the efficacy of the suPAR-guided medical intervention. SUPERIOR took place between November 2018
and December 2020. Multivariate stepwise Cox regression was used for the prospective cohort, while univariate
and multivariate logistic regression was used for the RCT. Consecutive admissions at the emergency department (ED)
with suspected infection, qSOFA 1 and suPAR ≥ 12 ng/mL were allocated to single infusion of placebo or meropenem.
The primary endpoint was early deterioration, defined as at least one-point increase of admission Sequential Organ
Failure Assessment (SOFA) score the first 24 h.

Results:

Most of the mortality risk was for patients with qSOFA 2 and 3. Taking the hazard ratio (HR) for death
of patients with qSOFA = 1 and suPAR < 12 ng/mL as reference, the HR of qSOFA = 1 and suPAR ≥ 12 ng/mL for 28-day
mortality was 2.98 (95% CI 2.11–3.96). The prospective RCT was prematurely ended due to pandemia-related ED
re-allocations, with 91 patients enrolled: 47 in the placebo and 44 in the meropenem arm. The primary endpoint
was met in 40.4% (n = 19) and 15.9% (n = 7), respectively (difference 24.5% [5.9–40.8]; odds ratio 0.14 [0.04–0.50]). One
post hoc analysis showed significant median changes of SOFA score after 72 and 96 h equal to 0 and − 1, respectively.

Conclusions:

Combining qSOFA 1 with the biomarker suPAR improves its prognostic performance for unfavorable
outcome and can help decision for earlier treatment.

1000+

published suPAR studies in leading medical journals

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