ArticleTrials2018
ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study): study protocol for a randomized controlled trial.
Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02647554 (A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients With Sepsis and Septic Shock in China), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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.
A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients With Sepsis and Septic Shock in China
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Improvement of Sepsis Prognosis by Ulinastatin: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Frontiers in pharmacology · 2019Pooled it
- An Applied Study of Ulinastatin in Pain Management After Hip Replacement: Impact on Opioid Use.Journal of pain research · 2024Trial
- Clinical efficacy of ulinastatin in the treatment of unliquefied pyogenic liver abscess complicated by septic shock: A randomized controlled trial.Immunity, inflammation and disease · 2023Trial
- Deriving consensus sepsis clusters via goal-directed subgroup identification in multi-omics study.Nature communications · 2025Article
- The Effect of Hybrid Blood Purification Combined with Ulinastatin for the Treatment of Severe Sepsis on APACHE II Score and Levels of miR-146a and miR-155.International journal of general medicine · 2024Article
- Article
- High-dose ulinastatin to prevent late-onset acute renal failure after orthotopic liver transplantation.Renal failure · 2020Article
- [Mechanism of ulinastatin in reducing lung inflammatory injury in rats with hemorrhagic shock].Nan fang yi ke da xue xue bao = Journal of Southern Medical University · 2019Article
- Efficacy of Xuebijing Injection for Sepsis (EXIT-SEP): protocol for a randomised controlled trial.BMJ open · 2019Article
- Inter-alpha Inhibitor Proteins Modulate Neuroinflammatory Biomarkers After Hypoxia-Ischemia in Neonatal Rats.Journal of neuropathology and experimental neurology · 2019Article
- Use of ulinastatin was associated with reduced mortality in critically ill patients with sepsis.Journal of thoracic disease · 2019Article
- Ulinastatin is effective in reducing mortality for critically ill patients with sepsis: a causal mediation analysis.Scientific reports · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 13 institutions in 1 country.
Funding
Abstract
backgroundSepsis is a major challenge in critical care and is associated with high mortality. Current management of sepsis and septic shock remains mainly supportive. Both basic and clinical research has shown that ulinastatin can improve the prognosis of sepsis. The aim of this trial is to evaluate the efficacy and safety profiles of ulinastatin compared with placebo. METHODS/
designIn this multi-center, double-blind, randomized placebo-controlled trial we are recruiting a total of 348 subjects meeting "The Third International Consensus Definitions for Sepsis and Septic Shock" (Sepsis-3). Subjects will be randomized (1:1) to receive ulinastatin 400,000 IU three times a day for 10 days or matching placebo and usual care simultaneously. The primary outcome is 28-day all-cause mortality. Adverse events and serious adverse events will be monitored closely. DISCUSSION: ADJUST is a large, multi-center, double-blind, randomized, parallel-group, placebo-controlled trial of ulinastatin in mainland China and is well-designed on the basis of previous studies. The results of this trial may help to provide evidence-based recommendations for treatment of sepsis.
trial registrationClinicalTrials.gov, ID: NCT02647554 . First registered on 27 December 2015, and last verified in December of 2016. Protocol version: 2.1, verified on 19 July 2016.
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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.