Trial reportCritical care medicine2017
Relationship Between Alternative Resuscitation Strategies, Host Response and Injury Biomarkers, and Outcome in Septic Shock: Analysis of the Protocol-Based Care for Early Septic Shock Study.
Trial report in Critical care medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.
What it found
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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
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
35 citing papers in PubMed.
- Mortality Benefit of Recombinant Human Interleukin-1 Receptor Antagonist for Sepsis Varies by Initial Interleukin-1 Receptor Antagonist Plasma Concentration.Critical care medicine · 2018Trial
- Endothelial Permeability and Hemostasis in Septic Shock: Results From the ProCESS Trial.Chest · 2017Trial
- Timing of hemoadsorption in sepsis: redefining early through mediator-guided therapy.Journal of intensive care · 2026Review
- Blood biomarker trajectories in ICU-directed prediction models - A scoping review.The EPMA journal · 2026Review
- Efficacy and prognostic analysis of the oXiris® filter in sepsis-associated acute kidney injury.International urology and nephrology · 2025Article
- Establishment and validation of the prediction model based on lymphocyte subsets for acute kidney injury in sepsis patients.Frontiers in immunology · 2025Article
- Early identification and diagnosis, pathophysiology, and treatment of sepsis-related acute lung injury: a narrative review.Journal of thoracic disease · 2024Review
- Patterns of inflammatory immune responses in patients with septic shock receiving vitamin C, hydrocortisone, and thiamine: clustering analysis in Korea.Acute and critical care · 2023Article
- Article
- Rationale for sequential extracorporeal therapy (SET) in sepsis.Critical care (London, England) · 2023Review
- Effect of Fluid Resuscitation Strategies for Obese Patients with Sepsis and Septic Shock: A Systematic Review.Intensive care research · 2023Review
- Discrepancy of C-Reactive Protein, Procalcitonin and Interleukin-6 at Hospitalization: Infection in Patients with Normal C-Reactive Protein, Procalcitonin and High Interleukin-6 Values.Journal of clinical medicine · 2022Article
- Proteomic changes associated with racial background and sepsis survival outcomes.Molecular omics · 2022Article
- Article
- Subtypes and Mimics of Sepsis.Critical care clinics · 2022Review
- Insight Into Regulatory T Cells in Sepsis-Associated Encephalopathy.Frontiers in neurology · 2022Review
- Regulatory T Cells: Angels or Demons in the Pathophysiology of Sepsis?Frontiers in immunology · 2022Review
- Wogonin alleviates liver injury in sepsis through Nrf2-mediated NF-κB signalling suppression.Journal of cellular and molecular medicine · 2021Article
- Interleukin-6: obstacles to targeting a complex cytokine in critical illness.The Lancet. Respiratory medicine · 2021Review
- Galectin-3 in septic acute kidney injury: a translational study.Critical care (London, England) · 2021Observational
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
objectivesThe Protocol-based Care for Early Septic Shock trial found no differences across alternative resuscitation strategies in all-cause mortality. A separate aim was to determine whether differences in resuscitation strategies affected trajectories of biomarkers of key pathways associated with downstream clinical outcomes of sepsis and whether there were differences in survival across treatment arms for patients with different baseline biomarker profiles.
designSecondary analysis of a large randomized clinical trial.
settingThirty-one U.S. hospitals. PATIENTS: Six hundred twenty-eight patients with septic shock.
interventionsTwo resuscitation protocols versus usual care. MEASUREMENTS AND MAIN
resultsWe measured a panel of biomarkers representing four pathophysiologic domains: "inflammation" (tumor necrosis factor, interleukin-6, and -10); "coagulation" (D-dimers, thrombin-antithrombin complex); "oxidative stress" (urine isoprostane); and "tissue hypoxia" (lactate) at 0, 6, 24, and 72 hours after treatment. We analyzed whether alternative resuscitation strategies affected biomarker trajectories over 72 hours and whether effects on 90-day hospital mortality varied by baseline (time 0) biomarker profiles-both using regression models with interaction terms for treatment arms. For all baseline biomarkers, higher concentrations were associated with increased risk of death by 90 days. However, there was no significant effect of treatment assignment on subsequent biomarker trajectories. We did find evidence for heterogeneity of treatment effect of protocol-based care on mortality for patients with different baseline [interleukin-6] and [interleukin-6] × [interleukin-10] profiles, whereas patients with the lowest quartiles fared better with protocol-based care (odds ratios, 0.32 [0.13-075]; p = 0.01 and 0.32 [0.14-0.73]; p = 0.01, respectively).
conclusionsIn patients with septic shock, alterations in inflammation, coagulation, oxidative stress, and tissue hypoxia are common and associated with adverse outcomes but are not influenced by protocol-based resuscitation compared with usual care. However, contrary to expectation, protocol-based resuscitation appeared to be superior in patients with lower concentrations of inflammatory biomarkers. The mechanisms responsible for this effect are unclear.
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