Trial reportScientific reports2024
Identification of a hyperinflammatory sepsis phenotype using protein biomarker and clinical data in the ProCESS randomized trial.
Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 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
25 citing papers in PubMed, 25 citations in OpenAlex.
- Randomized clinical trial of ventilator liberation with pressure support ventilation versus therapist-implement patient-specific weaning in prolonged weaning patients via tracheostomy.BMC pulmonary medicine · 2026Trial
- Relationship Between Phenotyping and Individualized Absolute Risk Differences in Sepsis: A Secondary Analysis of Two Approaches in Two Multicenter Trials.Critical care explorations · 2025Trial
- Molecular Phenotyping of Sepsis and Differential Response to Fluid Resuscitation.American journal of respiratory and critical care medicine · 2025Trial
- Host-directed immune therapies: a second front in the battle against sepsis.The Journal of clinical investigation · 2026Review
- Development and Validation of a Nomogram for Mortality Prediction in Septic Patients with Prolonged or Chronic Critical Illness.Diagnostics (Basel, Switzerland) · 2026Article
- Correlation analysis of serum FGF9, Sestrin2 and HBDH with the severity of sepsis.Journal of medical biochemistry · 2026Article
- Challenges in early detection and prognostication of sepsis: new approaches from the emergency department and intensive care unit.EClinicalMedicine · 2026Review
- Machine Learning Model for Sepsis Prediction in Prolonged and Chronic Critical Illness: Development and Validation Using Retrospective Real-World ICU Data.Journal of clinical medicine · 2026Article
- Implementation of a Sepsis Code Protocol at an Academic Institution in Colombia: A Pilot Study.Journal of clinical medicine · 2026Article
- Early enteral nutrition and dynamic metabolic-inflammatory trajectories in sepsis: a retrospective cohort study.Frontiers in medicine · 2026Article
- Identification and Characterization of Sepsis Phenotypes in an Indian Cohort.Critical care research and practice · 2026Article
- Article
- Prediction of Hyperinflammatory Phenotypes in Critically Ill Patients via Routine Clinical Data and IL-6: Towards Personalized Anti-Inflammatory Therapy.International journal of molecular sciences · 2025Article
- Finding the Four-Leaf CLOVERS: Biologic Subphenotypes and Fluid Tolerance in Sepsis.American journal of respiratory and critical care medicine · 2025Article
- The Impact of Inflammatory Biomarker Subphenotypes on Acute Respiratory Distress Syndrome Prognosis: A Systematic Review and Meta-analysis.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2025Review
- Rapid and Differential Diagnosis of Sepsis Stages Using an Advanced 3D Plasmonic Bimetallic Alloy Nanoarchitecture-Based SERS Biosensor Combined with Machine Learning for Multiple Analyte Identification.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Unsupervised clustering for sepsis identification in large-scale patient data: a model development and validation study.Intensive care medicine experimental · 2025Article
- Decoding Sepsis Globally: Toward Precision Medicine through Clustering in Sub-Saharan Africa.American journal of respiratory and critical care medicine · 2025Article
- Blood absolute lymphocyte count and trajectory are important in understanding severe COVID-19.BMC infectious diseases · 2025Article
- Aiming for precision: personalized medicine through sepsis subtyping.Burns & trauma · 2025Review
Corrections and comments
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Authors and funding
11 authors at 6 institutions in 2 countries.
Funding
Abstract
Sepsis is a heterogeneous syndrome and phenotypes have been proposed using clinical data. Less is known about the contribution of protein biomarkers to clinical sepsis phenotypes and their importance for treatment effects in randomized trials of resuscitation. The objective is to use both clinical and biomarker data in the Protocol-Based Care for Early Septic Shock (ProCESS) randomized trial to determine sepsis phenotypes and to test for heterogeneity of treatment effect by phenotype comparing usual care to protocolized early, goal-directed therapy(EGDT). In this secondary analysis of a subset of patients with biomarker sampling in the ProCESS trial (n = 543), we identified sepsis phenotypes prior to randomization using latent class analysis of 20 clinical and biomarker variables. Logistic regression was used to test for interaction between phenotype and treatment arm for 60-day inpatient mortality. Among 543 patients with severe sepsis or septic shock in the ProCESS trial, a 2-class model best fit the data (p = 0.01). Phenotype 1 (n = 66, 12%) had increased IL-6, ICAM, and total bilirubin and decreased platelets compared to phenotype 2 (n = 477, 88%, p < 0.01 for all). Phenotype 1 had greater 60-day inpatient mortality compared to Phenotype 2 (41% vs 16%; p < 0.01). Treatment with EGDT was associated with worse 60-day inpatient mortality compared to usual care (58% vs. 23%) in Phenotype 1 only (p-value for interaction = 0.05). The 60-day inpatient mortality was similar comparing EGDT to usual care in Phenotype 2 (16% vs. 17%). We identified 2 sepsis phenotypes using latent class analysis of clinical and protein biomarker data at randomization in the ProCESS trial. Phenotype 1 had increased inflammation, organ dysfunction and worse clinical outcomes compared to phenotype 2. Response to EGDT versus usual care differed by phenotype.
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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.