The DOI matches its Crossref record; the references it cites are not checked yet.
Effect of the 1-h bundle on mortality in patients with suspected sepsis in the emergency department: a stepped wedge cluster randomized clinical trial
Abstract
Purpose The efficacy of the 1-h bundle for emergency department (ED) patients with suspected sepsis, which includes lactate measurement, blood culture, broad-spectrum antibiotics administration, administration of 30 mL/kg crystalloid fluid for hypotension or lactate ≥ 4 mmol/L, remains controversial. Methods We carried out a pragmatic stepped-wedge cluster-randomized trial in 23 EDs in France and Spain. Adult patients with Sepsis-3 criteria or a quick sequential organ failure assessment (SOFA) score ≥ 2 or a lactate > 2 mmol/L were eligible. The intervention was the implementation of the 1-h sepsis bundle. The primary outcome was in-hospital mortality truncated at 28 days. Secondary outcomes included volume of fluid resuscitation at 24 h, acute heart failure at 24 h, SOFA score at 72 h, intensive care unit (ICU) length of stay, number of days on mechanical ventilation or renal replacement therapy, vasopressor free days, unnecessary antibiotic administration, and mortality at 28 days. 1148 patients were planned to be analysed; the study period ended after 873 patients were included. Results 872 patients (mean age 66, 42% female) were analyzed: 387 (44.4%) in the intervention group and 485 (55.6%) in the control group. Median SOFA score was 3 [1-5]. Median time to antibiotic administration was 40 min in the intervention group vs 113 min in the control group (difference - 73 [95% confidence interval (CI) - 93 to - 53]). There was a significantly higher rate, volume, and shorter time to fluid resuscitation within 3 h in the intervention group. There were 47 (12.1%) in-hospital deaths in the intervention group compared to 61 (12.6%) in the control group (difference in percentage - 0.4 [95% CI - 5.1 to 4.2], adjusted relative risk (aRR) 0.81 [95% CI 0.48 to 1.39]). There were no differences between groups for other secondary endpoints. Conclusions Among patients with suspected sepsis in the ED, the implementation of the 1-h sepsis bundle was not associated with significant difference in in-hospital mortality. However, this study may be underpowered to report a statistically significant difference between groups.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
The citation lists haven’t been fetched yet
References 22 · Cited by 35
Research works printed but not linked: 16
- Rudd KE, Johnson SC, Agesa KM et al (2020) Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study. Lancet 395(10219):200–211 · DOI · Paper page
- Rivers E, Nguyen B, Havstad S et al (2001) Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 345(19):1368–1377 · DOI · Paper page
- Kumar A, Roberts D, Wood KE et al (2006) Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med 34(6):1589–1596 · DOI · Paper page
- Levy MM, Evans LE, Rhodes A (2018) The Surviving Sepsis Campaign bundle: 2018 update. Intensive Care Med 44(6):925–928 · DOI · Paper page
- Evans L, Rhodes A, Alhazzani W et al (2021) Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med 47(11):1181–1247 · DOI · Paper page
- Freund Y, Khoury A, Möckel M et al (2019) European Society of Emergency Medicine position paper on the 1-hour sepsis bundle of the Surviving Sepsis Campaign: expression of concern. Eur J Emerg Med 26(4):232 · DOI
- Marik PE, Farkas JD, Spiegel R, Weingart S, collaborating authors (2019) POINT: should the Surviving Sepsis Campaign guidelines be retired? Yes. Chest 155(1):12–14 · DOI
- Hemming K, Taljaard M, Grimshaw J (2019) Introducing the new CONSORT extension for stepped-wedge cluster randomised trials. Trials 20(1):68 · DOI
- Freund Y, Lemachatti N, Krastinova E et al (2017) Prognostic accuracy of sepsis-3 criteria for in-hospital mortality among patients with suspected infection presenting to the Emergency Department. JAMA 317(3):301–308 · DOI
- Hemming K, Taljaard M (2016) Sample size calculations for stepped wedge and cluster randomised trials: a unified approach. J Clin Epidemiol 69:137–146 · DOI · Paper page
- Levy MM, Rhodes A, Evans LE, Steering and Executive Committee of the Surviving Sepsis Campaign (2019) COUNTERPOINT: should the Surviving Sepsis Campaign guidelines be retired? No. Chest 155(1):14–17 · DOI
- Sterling SA, Miller WR, Pryor J, Puskarich MA, Jones AE (2015) The impact of timing of antibiotics on outcomes in severe sepsis and septic shock: a systematic review and meta-analysis. Crit Care Med 43(9):1907–1915 · DOI · Paper page
- Kalantari A, Rezaie SR (2019) Challenging the one-hour sepsis bundle. West J Emerg Med 20(2):185–190 · DOI
- Marik PE (2020) The management of sepsis: science & fiction. J Thorac Dis 12(Suppl 1) [Internet] [cited 2024 Feb 29]. Available from: https://jtd.amegroups.org/article/view/34724 · DOI
- Rhodes A, Phillips G, Beale R et al (2015) The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Med 41(9):1620–1628 · DOI
- ARISE Investigators, ANZICS Clinical Trials Group, Peake SL et al (2014) Goal-directed resuscitation for patients with early septic shock. N Engl J Med 371(16):1496–1506 · DOI
Metadata
- Authors
- Freund, Y., Cancella de Abreu, M., Lebal, S., Rousseau, A., Lafon, T., Yordanov, Y., Macrez, R., Coisy, F., Le Borgne, P., Femy, F., Douillet, D., Boter, N. R., Eyer, X., Bouillon-Minois, J.-B., Ogereau, C., Bouzid, D., Goulet, H., Roussel, M., Rousseau, G., Guénézan, J., Occelli, C., Chouihed, T., Osorio Quispe, G., Renard, M. C., Gorlicki, J., Bloom, B., Simon, T., & Gerlier, C.
- Affiliations
- Sorbonne Université (FR)
- Hôpital Universitaire Dupuytren (FR)
- Inserm (FR)
- Centre Hospitalier Universitaire de Nîmes (FR)
- Centre National de la Recherche Scientifique (FR)
- Hospital Universitari Germans Trias i Pujol (ES)
- Hôpital Fernand-Widal (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Université Paris Cité (FR)
- Centre Hospitalier Universitaire de Rouen (FR)
- Centre Hospitalier Universitaire de Tours (FR)
- Centre Hospitalier Régional et Universitaire de Nancy (FR)
- Barcelona Biomedical Research Park (ES)
- Barts Health NHS Trust (GB)
- Hôpital Paris Saint-Joseph (FR)
- Corresponding author
- Freund, Yonathan
- ORCID
- Venue
- Intensive Care Medicine
- Published
- 2024-06-24
- Volume
- 50
- Issue
- 7
- Pages
- 1086-1095
- ISSN
- 0342-4642 (ISSN-L)
- 1432-1238
- OpenAlex
- W4399971245
- Cited by
- 35
- References
- 22
- Citations by year
- 2026: 14 · 2025: 15 · 2024: 6
- FWCI
- 10.68
- Type
- journal article
- Language
- en
- Update notices
- correction (2024-08-12)
- Open access
- closed
- Licence
- Locations
- Intensive Care Medicine (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Funders
- Direction Générale de l’offre de Soins
- Topics
- Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Sepsis Diagnosis and Treatment
- Health Sciences › Medicine › Surgery › Abdominal Surgery and Complications
- Health Sciences › Medicine › Emergency Medicine › Emergency and Acute Care Studies
- Keywords
- sepsis, emergency department, in-hospital mortality, fluid resuscitation, lactate measurement, blood culture, broad-spectrum antibiotics, SARS-CoV-2, COVID-19 vaccination, COVID-19 pandemic, SOFA score, vasopressors, ICU length of stay, mechanical ventilation
- MeSH terms
- Aged, Anti-Bacterial Agents, Emergency Service, Hospital, Female, Fluid Therapy, France, Humans, Intensive Care Units, Length of Stay, Male, Middle Aged, Spain, Hospital Mortality, Sepsis, Organ Dysfunction Scores, Patient Care Bundles
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
