Interventions The study group and the control group will receive ulinastatin , IU every 8 h and placebo, respectively, for 10 days, with the first dose administered within 8 h of study enrollment. For details of organisms causing sepsis and antibiotics used, see Electronic Supplementary Material. Minimization as the most common covariate-adaptive randomization was adopted in our trial, which derived from the method of Pocock and Simon [ 32 ]. This article needs additional citations for verification. The outcomes, mortality and length of hospital stay, were compared across different groups and subgroups. Cochrane Database Syst Rev 7: Continuous variables are reported as means and standard deviations or medians and interquartile ranges.

Urinary trypsin inhibitor suppresses excessive generation of superoxide anion radical, systemic inflammation, oxidative stress, and endothelial injury in endotoxemic rats. This article has been cited by other articles in PMC. Protein targets of inflammatory serine proteases and cardiovascular disease. The results indicated that in this population, one life would be saved for every 6. Aibiki M, Cook JA. Machado and colleagues reported a hospital mortality rate up to

J Nat Sci Biol Med ; 5: Each subject will be given a unique participant identification number after study enrollment. The median duration of hospital LOS was higher in the ulinastatin group, both in survivors 61 days vs Sepsis was defined as evidence of infection defined as presence of white blood cells in a normally sterile body fluid, perforated abdominal viscus, evidence of pneumonia, or presence of a condition associated with a high risk of bacterial infection, e. The dosage may be adjusted according to patients’ age and the severity of symptoms.


Relevant data were obtained from archived patient files.

ulinastatin case study

Consent for publication Not applicable. It is a global public health problem with an estimated 4. Immunomodulatory therapy for sepsis: Based on these mechanisms and clinical evidence, ulinastatin is approved for management of conditions like sepsis, acute pancreatitis, and acute circulatory failure due to hemorrhagic, bacterial, or traumatic shock syudy countries like Japan, China, South Korea, and India.

Impact of Ulinastatin on Outcomes in Acute Burns Patients

Clinical effect of ulinastatin in the treatment of septic shock. Shorter duration of hospitalization is associated with death and, thus, is not a predictor of mortality ulinastatkn rather a consequence of the outcome. Follow-up will be attended by study staff by either direct contact with the patient or their next of kin. Correlation between mortality and the levels of inter-alpha inhibitors in the plasma of patients with severe sepsis. This primary analysis population included all randomized patients who had received at least six doses of the study medication.

KarnadRakesh BhadadePradeep K.

Burns is a global health problem with significant morbidity and mortality. Ulinastatin, a serine protease inhibitor, inhibits several pro-inflammatory proteases and decreases inflammatory cytokine levels and mortality in experimental sepsis.


Many of the intermediaries in the systemic inflammatory processes are serine proteases. Learn how and when to remove these template messages. Ulinastatin, a serine protease inhibitor, has the potential to improve outcomes in burns.

ulinastatin case study

Of the four deaths in the ulinastatin group one patient each died as a result of ARDS, acute renal failure, refractory shock, and multiple organ failure.


Author information Article notes Copyright and License information Disclaimer. Several preclinical studies have shown a reduction in the systemic inflammatory response and organ dysfunction due to sepsis in animals treated with ulinastatin [ 13 — 17 ].

Epidemiology of burned patients admitted in burn unit ztudy a rural tertiary etudy hospital. N Engl J Med.

Open in a separate window. The primary endpoint showed significant reduction of day all-cause mortality in the modified ITT population. Ulinasttain J Contemp Pediatr. Urinary trypsin inhibitor suppresses excessive generation of superoxide anion radical, systemic inflammation, oxidative stress, and endothelial injury in endotoxemic rats.

Impact of Ulinastatin on Outcomes in Acute Burns Patients

Baseline ulinastatn in patients with severe sepsis randomized to placebo and ulinastatin treatment groups. Interim analysis No interim analysis is planned for this trial. Data on patient demographics, burn details, major interventions, medications including antibiotics, blood and blood components, and I.

In one study, the incidence of hyperenzymemia and pancreatitis was significantly lower in the ulinastatin group than in the placebo group. Unsourced material may be challenged and removed. This study was funded by Bharat Serums and Vaccines Limited, India who provided the study medications, administrative assistance, and study grants to cass centers and funded the statistical analysis by an external statistician.