Trial reportInfection2025
Clinical value of circulating bioactive adrenomedullin for prediction of outcome and hydrocortisone response in sepsis patients-a post-hoc analysis of the HYPRESS trial.
Trial report in Infection, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00670254 (Placebo-controlled, Randomised, Double-blind Study to Investigate the Efficacy and Safety of Low Dose Hydrocortisone to Prevent the Development of Septic Shock in Patients With Severe Sepsis), which is not on this map. Not yet cited in PubMed.
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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.
The trial behind it
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Placebo-controlled, Randomised, Double-blind Study to Investigate the Efficacy and Safety of Low Dose Hydrocortisone to Prevent the Development of Septic Shock in Patients With Severe Sepsis
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Authors and funding
11 authors.
Funding
Abstract
purposeSepsis requires stratification for host-directed therapies through the discovery of adequate biomarkers enabling prediction of outcomes and treatment responses. Adrenomedullin has previously demonstrated potential for prognostic enrichment. This study aimed to assess associations of bioactive adrenomedullin (bio-ADM) levels at ICU admission and sepsis outcomes and to evaluate the potential of bio-ADM as marker to identify subgroups of patients with moderate disease severity that might benefit from hydrocortisone treatment.
methodsWe used data from the HYPRESS trial (NCT00670254) to investigate, if bio-ADM is useful to predict sepsis outcomes (septic shock, 90- and 180-day mortality) and benefit or harm by hydrocortisone treatment. Optimal cut-offs for outcome predictions were determined by Youden's index. Logistic regression was used to assess bio-ADM subgroups and treatment interaction.
resultsBio-ADM levels differed significantly in patients with or without septic shock within 14 days (p = 0.011). While the area under the ROC curve (AUC) was only 0.603 (CI 0.531-0.676), patient subgrouping using bio-ADM levels showed significantly higher cumulative incidence of septic shock within 14 days in the subgroup of patients with bio-ADM levels ≥ 37 pg/mL (p < 0.001). The odds ratio for the development of septic shock in this group was 4.67 (95% CI 1.53, 20.3, p = 0.016). A bio-ADM cut-off of ≥ 136 pg/mL was predictive for 90-day (OR 8.21, 95% CI 2.46-27.9, p < 0.001) and 180-day mortality (OR 4.87, 95% CI 1.49-16.0, p = 0.008). Hydrocortisone therapy did not reduce the incidence of septic shock (OR 1.59, 95% CI 0.37-8.15, p = 0.54), 90-day (OR 1.53, p = 0.23) or 180-day mortality (OR 1.41, p = 0.25), regardless of bio-ADM stratification (interaction term p = 0.58 for septic shock; p = 0.31 for 90-day mortality; p = 0.51 for 180-day mortality).
conclusionsWhereas bio-ADM levels are associated with sepsis outcomes, our data do not indicate usefulness of the marker to identify patients potentially benefitting from hydrocortisone therapy.
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