Evidence map›Paper›PMID 38321472›Full record

Trial reportCritical care (London, England)2024

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

Maria Evangelia Adami, Antigone Kotsaki, Nikolaos Antonakos, Efthymia Giannitsioti, Stamatios Chalvatzis, Maria Saridaki, Christina Avgoustou, Karolina Akinosoglou, Konstantina Dakou, Georgia Damoraki and 7 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03717350 (A suPAR Guided Double-blind Randomized Clinical Trial of Initiation of Antibiotics for Presumed Infection at the Emergency Department), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03717350 phase2 / phase3unknown statusnot on this map

A suPAR Guided Double-blind Randomized Clinical Trial of Initiation of Antibiotics for Presumed Infection at the Emergency Department

TypeinterventionalSponsorHellenic Institute for the Study of SepsisRan2018 to 2021Enrolled220ConditionsSepsisArmsMeropenem, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Biomarkers to guide sepsis management.Annals of intensive care · 2025
    Review
  8. Article
  9. Article
  10. Observational
  11. Observational
  12. Early sepsis recognition: how difficult can this be?Critical care (London, England) · 2024
    Article
  13. Review
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 3 institutions in 2 countries.

Maria Evangelia AdamiFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Antigone KotsakiFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Nikolaos AntonakosFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Efthymia GiannitsiotiFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Stamatios ChalvatzisFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Maria SaridakiFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Christina AvgoustouFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Karolina AkinosoglouDepartment of Internal Medicine, University of Patras, Rion, Greece.
Konstantina DakouHellenic Institute for the Study of Sepsis, Athens, Greece.
Georgia DamorakiFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Konstantina KatriniFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Panagiotis KoufargyrisFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Vasileios LekakisFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Antonia PanagakiFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Asimina SafarikaFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece.
Jesper Eugen-OlsenDepartment of Clinical Research, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.
Evangelos J Giamarellos-BourboulisFourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, ATTIKON University General Hospital, 1 Rimini Str, 124 62, Athens, Greece. egiamarel@med.uoa.gr.
National and Kapodistrian University of Athens · GRCopenhagen University Hospital · DKUniversity of Patras · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSepsis 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.

methodsThe 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.

resultsMost 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.

conclusionsCombining qSOFA 1 with the biomarker suPAR improves its prognostic performance for unfavorable outcome and can help decision for earlier treatment. Trial registration EU Clinical Trials Register (EudraCT, 2018-001008-13) and Clinical-Trials.gov (NCT03717350). Registered 24 October 2018.

Indexed as

Organ Dysfunction ScoresSepsisAnti-Bacterial AgentsEmergency Service, HospitalHospital MortalityHumansMeropenemPrognosisReceptors, Urokinase Plasminogen ActivatorRetrospective StudiesROC CurveAnti-Bacterial AgentsMeropenemReceptors, Urokinase Plasminogen ActivatorMeropenemRiskSepsissuPAR

Identifiers

PMID38321472
PMCPMC10848347
OpenAlexW4391564905

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.