ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study): study protocol for a randomized controlled trial

Jiang, Wei; Yu, Xiangyou; Sun, Tongwen; Chai, Yifeng; Chang, Ping; Chen, Zhongqing; Pan, Jingye; Peng, Zhiyong; Wang, Ruilan; Wang, Xiaozhi; Xu, Yuan; Yu, Li; Zheng, Qingshan; Du, Bin

doi:10.1186/s13063-018-2513-y

Cited by 12 publications

(8 citation statements)

References 42 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Thus, multicenter, large sample, randomized clinical trials are still urgently needed to further evaluate the effects of UTI in patients with sepsis. At present, ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study), a large sample, multi-center, double-blind, randomized, parallel-group, placebo-controlled trial is being conducted in mainland China (Jiang et al, 2018). The aim of this trial is to further evaluate the efficacy and safety profiles of UTI.…”

Section: Limitationsmentioning

confidence: 99%

Improvement of Sepsis Prognosis by Ulinastatin: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

et al. 2019

Self Cite

View full text Add to dashboard Cite

Background: Ulinastatin has been prescribed to treat sepsis. However, there is doubt regarding the extent of any improvement in outcomes to guide future decision making.Objectives: To evaluate the effects of ulinastatin on mortality and related outcomes in sepsis patients.Methods: Thirteen randomized controlled trials and two prospective studies published before September 1, 2018, that included 1358 patients with sepsis, severe sepsis, or septic shock were evaluated. The electronic databases searched in this study were PubMed, Medline, Embase, and China National Knowledge Infrastructure (CNKI) for Chinese Technical Periodicals.Results: Ulinastatin significantly decreased the all-cause mortality {odds ratio (OR) = 0.48, 95% confidence interval (CI) [0.35–0.66], p < 0.00001, I2 = 13%}, Acute Physiology, Age, Chronic Health Evaluation II (APACHE II) score {mean difference (MD) = −2.40, 95% CI [−4.37, −0.44], p = 0.02, I2 = 66%}, and reduced the incidence of multiple organ dysfunction syndrome (MODS) (OR = 0.3, 95% CI [0.18, 0.49], p < 0.00001, I2 = 0%). Ulinastatin also decreased the serum levels of IL-6 (MD = −88.5, 95% CI [−123.97, −53.04], p < 0.00001), TNF-α (MD = −56.22, 95% CI [−72.11, −40.33], p < 0.00001), and increased the serum levels of IL-10 (MD = 37.73, 95% CI [16.92, 58.54], p = 0.0004). Ulinastatin administration did not lead to any difference in the occurrence of adverse events.Conclusions: Ulinastatin improved all-cause mortality and other related outcomes in patients with sepsis or septic shock. The results of this meta-analysis suggest that ulinastatin may be an effective treatment for sepsis and septic shock.

show abstract

Section: Limitationsmentioning

confidence: 99%

Improvement of Sepsis Prognosis by Ulinastatin: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

et al. 2019

Self Cite

View full text Add to dashboard Cite

show abstract

“…This study shows that fluid resuscitation combined with ulinastatin have something to do with reducing mortality in sepsis patients after 30 d treatment. It has been reported that among 122 sepsis patients, there were one or more organ failure [13] treated with ulinastatin. It was found that in 28 d all-cause mortality in ulinastatin group was 7.3 % (4 deaths), while that in control group was 20.3 % (12 deaths) (p=0.045), which was the same as the results of our research.…”

Section: Resultsmentioning

confidence: 99%

Evaluation of the Clinical Efficacy of Liquid Resuscitation Combined with Ulinastatin in Patients with Sepsis

Sun¹,

Li²,

Wang³

et al. 2022

ijps

View full text Add to dashboard Cite

“…Third, the evolving definition of sepsis may also explain the conflicting results. While early trials defined sepsis as the infection plus systematic inflammatory response syndrome (SIRS) 23 , more recent trails and the present study enrolled patients with sepsis-3.0 criteria 26 . There is large body of evidence that sepsis identified by these two definitions can be quite different 1 , 27 .…”

Section: Discussionmentioning

confidence: 99%

Ulinastatin is effective in reducing mortality for critically ill patients with sepsis: a causal mediation analysis

Yan

Chen

2018

Sci Rep

View full text Add to dashboard Cite

Ulinastatin has been found to have anti-inflammatory effect for patients with sepsis. However, its clinical effects were conflicting. The study aimed to investigate the cost-effectiveness of ulinastatin and to perform mediation analysis to explore the proportion of the total effects that can be explained by inflammatory responses. This is a retrospective study involving critically ill patients with sepsis from January 2014 to July 2017. A total of 263 patients were included in the study, involving 179 patients in the ulinastatin group and 84 in the control group. Ulinastatin group showed significantly lower 28-day mortality rate than that in the control group (31% vs. 55%; p < 0.001). Both total (46330 [26000,83500] vs. 19870 [8747,41140] RMB; p < 0.01) and drug cost (18210 [9492,31920] vs. 7230 [2675,19270] RMB; p < 0.01) were significantly higher in the ulinastatin group than the control group. In multivariable model, the adjusted odds ratio for ulinastatin was 0.304 (95% CI: 0.152 to 0.592; p = 0.001). The mediation analysis showed that the use of ulinastatin was able to reduce the probability of death by 23.5%. The average causal mediation effect of delta C-reactive protein (CRP) was 8%, accounting for 35% of the total effect.

show abstract

ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study): study protocol for a randomized controlled trial

Cited by 12 publications

References 42 publications

Improvement of Sepsis Prognosis by Ulinastatin: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Improvement of Sepsis Prognosis by Ulinastatin: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Evaluation of the Clinical Efficacy of Liquid Resuscitation Combined with Ulinastatin in Patients with Sepsis

Ulinastatin is effective in reducing mortality for critically ill patients with sepsis: a causal mediation analysis

Contact Info

Product

Resources

About