It inactivates many serine proteases , including trypsin , chymotrypsin , kallikrein , plasmin , granulocyte elastase , cathepsin , thrombin , and factors IXa, Xa, XIa, and XlIa. The aim of this trial is to evaluate the efficacy and safety profiles of ulinastatin compared with placebo. As a result, the effect of ulinastatin on the mortality of sepsis warrants validation by large, well-conducted RCTs in different settings [ 50 ]. As a result, using data from China [ 23 ], we estimate that day all-cause mortality will be Ulinastatin improves survival of septic mice by suppressing inflammatory response and lymphocyte apoptosis. Comparison of anxiety, depression, and post-traumatic stress symptoms in relatives of ICU patients in an American and an Indian public hospital. However, the mortality difference did not reach statistical significance in the intention-to-treat analysis [

Mazumder A, Patowary A. This comprised patients admitted from October 05, , to April 27, , and formed the ulinastatin group. Harmful molecular mechanisms in sepsis. Treatment and mortality trends among massively burned patients. Finally, detailed study of associated morbidity was also not possible. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. The dosage may be adjusted according to patients’ age and the severity of symptoms.


DagaNeelima D. The new definition of Sepsis-3 focused on organ function, so apart from the regular endpoints in clinical trials, such as mortality of various timeframes, we would like to employ more outcome measurements for organ function, together with mechanism and physical function.

ulinastatin case study

Intensive Care Med ; Treatment with ulinastatin was independently associated with decreased mortality compared with treatment xtudy placebo after adjusting for other baseline characteristics including age, gender, Glasgow coma scale, specific organ system failure, number of organs failed, need for vasopressors and need for mechanical ventilation.

Effects of urinary trypsin inhibitor on lipopolysaccharide-induced acute lung injury in rabbits.

Ulinastatin – Wikipedia

Apart from ulinastatin treatment, all enrolled patients will receive standard care for sepsis and septic shock as per local protocols, including, but not limited to, antimicrobial agents, intravenously administered fluids, enterally or parenterally administered nutrition, transfusion of blood and blood products, and life-sustaining therapy e.


All tests are two-sided with no adjustment for multiple comparisons. Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author s and the source are credited.

A larger randomized controlled study with ulinastatin is needed to further confirm the survival benefit seen in this pilot study and also to investigate its mechanism of action in humans. Severe sepsis and septic shock.

Besides reduction in day all-cause mortality, ulinastatin ulinsatatin showed beneficial effects vase some secondary end-points in the present study like new-onset organ dysfunction. However, although ulinastatin is a protease inhibitor, its activity toward various proteases is ulinastatun weak. Ulinastatin, a human trypsin inhibitor, inhibits endotoxin-induced thromboxane B2 production in human monocytes.

In conclusion, this prospective, multicenter, randomized, double-blind, placebo-controlled pilot study in patients with severe sepsis investigated a novel therapy directed against the systemic inflammatory response. Its anti-metastatic properties may come from the inhibition of cell-bound plasmin activity. The mortality in the ulinastatin group Ulinastatin also potentiates local anti-proteolytic activity on the extracellular matrix ECM during tissue remodeling, possibly through noncovalent binding to TSG The mean duration of ulinastatin use was 8.

Clinical effects of ulinastatin in patients with severe burn sepsis. Prophylactic antibiotics most commonly a third generation cephalosporin were administered to all patients, while analgesics were given as required.

Impact of Ulinastatin on Outcomes in Acute Burns Patients

Inflamm Res ; Participants who withdraw from the study for any reason will be followed up according to the study follow-up schedule and analyzed on the ITT jlinastatin. All other authors participated as investigators in the clinical trial and also helped in preparing and reviewing the manuscript; their institutions received grants for this clinical trial.


N Engl J Med. Ulinastatin improves survival of septic mice by suppressing inflammatory response and lymphocyte apoptosis. We planned to collect data of organ dysfunction at baseline and various dtudy points during the study.

ulinastatin case study

A similarly sized cohort ulinasattin patients, admitted before the introduction of ulinastatin, was also identified. Of the randomized subjects, completed the study 55 subjects in the ulinastatin group and 59 subjects in the control group.

Impact of Ulinastatin on Outcomes in Acute Burns Patients

Serine protease inhibitor, Inflammatory mediators, Bacterial infection, Septic shock, Pneumonia, Abdominal sepsis. Machado and colleagues reported a hospital mortality rate up to Our study was limited to in-hospital events only and hence longer term outcomes have not been considered.

Chin J Contemp Pediatr. Protein targets of inflammatory serine proteases and cardiovascular disease. These, in turn, have widespread effects on other cells including inflammatory cells, immune response, endocrine and autonomic nervous systems, and vascular endothelium, mainly aimed at limiting spread or eliminating the infecting pathogen [ 3 — 6 ].

ulinastatin case study

This randomized, double-blind, placebo-controlled trial was conducted in the intensive care units ICUs of seven tertiary care hospitals in India; the study protocol was approved by the institutional review boards at each center. Forward stepwise multiple logistic regression analysis was used for assessment cass the primary end-point.

Patient enrollment is expected to last for up to 36 months.

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