A 1-hour sepsis bundle is associated with reduced short-term mortality compared to non-bundle care in a meta-analysis of 4435 patients.

This systematic review and meta-analysis investigated the relationship between the implementation of a 1-hour sepsis bundle and clinical outcomes in patients with sepsis. The study population comprised 4435 patients drawn from a heterogeneous mix of single-center and multicenter studies. These studies were conducted in intensive care unit (ICU) settings, emergency department settings, and included both prospective and retrospective designs. The comparator group consisted of patients managed with a non-1-hour bundle approach. The primary outcome assessed was short-term mortality, specifically including in-hospital mortality, 28-day mortality, and 30-day mortality. No secondary outcomes were reported in the available data.

The meta-analysis results indicate that the 1-hour bundle group demonstrated a short-term mortality rate of 20.8%, compared to 24.7% in the non-1-hour bundle group. The effect size for this primary outcome was reported with a 95% confidence interval (CI) of 0.69-0.84. When stratified by study setting, the association between the 1-hour bundle and reduced mortality was consistent in single-center studies, with an effect size of 95% CI 0.67-0.84. In multicenter studies, the effect size was 95% CI 0.65-0.95, also indicating a reduced mortality direction.

Subgroup analyses revealed significant variation based on study design and location. In prospective studies, a pronounced mortality benefit was observed, with an effect size of 95% CI 0.61-0.86. Similarly, in ICU settings, the analysis showed a pronounced mortality benefit with an effect size of 95% CI 0.63-0.80. Conversely, the mortality benefit was not pronounced in retrospective studies, where the effect size was 95% CI 0.63-1.02. In emergency department settings, the benefit was also not pronounced, with an effect size of 95% CI 0.71-1.05. The direction of effect was not reported for these latter two subgroups.

Regarding safety and tolerability, no data were reported for adverse events, serious adverse events, discontinuations, or general tolerability. Consequently, no specific rates or details regarding safety profiles could be extracted from the input data. The study design was a meta-analysis of observational and prospective/retrospective studies, and the funding or conflicts of interest were not reported.

Several methodological limitations must be considered when interpreting these findings. The certainty of the evidence is low, primarily due to the limited number of randomized trials included in the synthesis. Furthermore, the association between the 1-hour bundle and clinical outcomes should be understood as such, rather than a definitive causal relationship. The findings in emergency department settings and retrospective studies are particularly uncertain and should not be overstated. These limitations suggest that the observed benefits may be influenced by selection bias or confounding factors inherent in non-randomized designs.

For clinical practice, critical care providers, including nurses, may consider implementing the 1-hour bundle as part of standard care protocols for sepsis patients, especially within the ICU environment. This recommendation is tempered by the low certainty of the evidence. The data suggests a potential benefit in ICU and prospective settings, but the lack of safety data and the heterogeneity of study designs mean that universal adoption requires caution. Clinicians should weigh the potential mortality reduction against the resource requirements of implementing such a bundle.

Several questions remain unanswered regarding the optimal implementation of sepsis bundles. The lack of reported safety data leaves clinicians without information on potential harms associated with the bundle interventions. Additionally, the discrepancy between prospective and retrospective study results highlights the need for more robust randomized controlled trials to establish causality. Future research should aim to standardize reporting of adverse events and clarify the specific components of the 1-hour bundle that drive the observed outcomes in different care settings.