Trial reportDrugs in R&D2025
Efficacy and Safety of Ulinastatin in Post-traumatic Sepsis: A Randomized Controlled Trial.
Trial report in Drugs in R&D, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Targeting capillary leak in experimental sepsis and endotoxemia: a systematic review of therapeutic agents, methods and models in animal studies.Critical care (London, England) · 2026Pooled it
- Dose-Dependent Efficacy of Ulinastatin in Improving 28-Day and 30-Day Survival Rates in Sepsis: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
BACKGROUND AND
objectivePost-traumatic sepsis is associated with high mortality and limited treatment options. This study aimed to evaluate the safety and efficacy of ulinastatin in adult patients with post-traumatic sepsis, assess its potential as a therapeutic option, and provide a foundation for future large-scale trials.
methodsA single-blind, randomized controlled trial was conducted involving 60 patients treated at the Eastern Theater General Hospital from October 2022 to June 2024. The primary endpoint was 28-day all-cause mortality. Secondary endpoints included the Sequential Organ Failure Assessment (SOFA) score, C-reactive protein (CRP), interleukin-6 (IL-6), procalcitonin (PCT) levels, Activities of Daily Living (ADL) score, Acute Physiology and Chronic Health Evaluation II (APACHE II) score, ICU length of stay, duration of mechanical ventilation, and other laboratory indicators.
resultsNo statistically significant difference was observed in 28-day mortality between the ulinastatin and control groups (p > 0.05). However, the ulinastatin group exhibited significantly shorter ICU and hospital stays compared with the control group (p < 0.05), while the duration of mechanical ventilation showed no significant difference (p > 0.05). The ulinastatin group demonstrated significant improvements in CRP, IL-6, PCT levels, as well as SOFA and APACHE II scores (p < 0.05). Safety evaluations revealed a significant reduction in ALT and AST levels in the ulinastatin group (p < 0.05), with no serious adverse events reported.
conclusionWhile the 28-day mortality rate did not differ significantly between the two groups, ulinastatin was associated with shorter ICU and hospital stays, improvements in inflammatory markers and organ function, and demonstrated a favorable safety profile.
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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.