Accessed 1 June Ulinastatin improves survival of septic mice by suppressing inflammatory response and lymphocyte apoptosis. However, our study had some strengths too. Sepsis is a major challenge in critical care and is associated with high mortality. However, the mortality difference did not reach statistical significance in the intention-to-treat analysis [ Each subject will be given a unique participant identification number after study enrollment.

This was a small, retrospective case note study, and comprehensive details of important variables like serial values of laboratory parameters at specific time points, development of infection, surgical intervention, need for blood transfusion, presence of multiresistant bacteria in wound, presence of fungi in wound, etc were not available for analysis and hence not studied. Contributor Information Wei Jiang, Email: A new immunomodulatory therapy for severe sepsis: An analysis of 11, burn admissions and evaluation of conservative management techniques. Ann Chir Gynaecol ; These two factors alone could add up to 18 points per patient 6 for age and 12 for coma , accounting for high APACHE II scores in studies from western countries.

Impact of Ulinastatin on Outcomes in Acute Burns Patients

Antitetanus ulinastztin was provided as required. Topical antibiotics and wound dressings were applied in layers. The principle investigator, Professor Bin Du, will be paid a management fee for this trial according to the contract.

Indian J Crit Care Med. Ulinastatin was stopped based on clinical improvement and normalization of laboratory parameters, indicating improvement in organ functions. The effects of urinary trypsin inhibitor on the outcomes of severe sepsis and septic shock patients.

Protective effect of ulinastatin against murine models of sepsis: Such data were still lacking in middle- and low-income countries MLICs. Dynamic randomization will be carried out using a Distribution Annotation Interactive Web Response System through a central, secured website: Confidentiality Each subject will be given a unique participant identification number after study enrollment.


Shorter duration of hospitalization is associated with death and, thus, is not a predictor of mortality but rather a consequence of the outcome. The investigator will unblind allocation to the ulinastatin or placebo group should treatment of study-related adverse events AEs require it. Based on these results, we presume that a treatment effect with a RRR of 0. Please review our privacy policy.


Small randomized controlled trials have also been conducted by a single group of investigators comparing standard treatment with intravenous administration of ulinastatin in combination with alpha thymosin and found a reduction of mortality in patients with severe sepsis [ 25 — 27 ].

Patients with larger burns often develop prolonged hypermetabolism, chronic inflammation, and lean body mass wasting, all of which may impair wound healing.

The ADJUST study is designed as a prospective, multi-center, double-blind, randomized, parallel-group, placebo-controlled ulinastatin vs placebo 1: Neurol Res ; A study conducted in India found that mortality from all causes over 22 days in subjects with severe pancreatitis was lower among those receiving ulinastatin than those receiving placebo 2. Effects of urinary trypsin inhibitor on lipopolysaccharide-induced acute lung injury in rabbits.

Ulinastatin – Wikipedia

Urinary trypsin inhibitor is one such important protease inhibitor found in human blood and urine; it has been also referred to in the literature as ulinastatin or bikunin [ 1011 ]. Matching placebo vials, with studg reconstitution and infusion instructions to the ulinastatin vials, will be administered on the same schedule.

ulinastatin case study

Urinary trypsin inhibitor suppresses excessive generation of superoxide anion radical, systemic inflammation, oxidative stress, and endothelial injury in endotoxemic rats. The patients from these two periods were divided into two groups and compared for outcomes. The safety and tolerance of multi-dose up to 1, IU qid of ulinastatin u,inastatin been evaluated in healthy volunteers without any serious adverse events SAEs [ 37 ].


ulinastatin case study

Mortality rates based on burnt BSA strata. Primary endpoint The primary endpoint of this study is day all-cause mortality. The results indicated that in this population, one life would be saved for every 6.

Levi M, van der Poll Ulinastarin. Studies in patients have shown that there casf a decrease in serum levels of ulinastatin in sepsis, with the lowest levels being found in patients with severe sepsis and septic shock [ 12 ].

It is recognized that the patient with sepsis will experience a number of aberrations in laboratory values, signs, and symptoms due to the severity of the underlying disease and the impact of standard critical medicine therapies.

Impact of Ulinastatin on Outcomes in Acute Burns Patients

Protective effects of urinary trypsin inhibitor on systemic inflammatory response induced by lipopolysaccharide. This study was funded by Bharat Serums and Vaccines Limited, India who provided the study medications, administrative assistance, and study grants to participating centers and funded the statistical analysis by an external statistician. The t test will be used for comparison of SOFA scores, life-sustaining interventions, lactic acid levels, fluid balance, inflammatory biomarkers, and function indicators between groups.

A recent meta-analysis reported that compared stury a control group, ulinastatin treatment could significantly decrease the day mortality rate The pathogenesis of sepsis is complex and is believed to be initiated by the interaction between pathogen-associated molecular patterns and pattern recognition receptors on host immune cells [ 34 ].