by the degree of inflammatory response mediated by a variety of cytokines.

Aim: To study the effect of addition of ulinastatin to standard care on mortality and morbidity in Indian subjects with acute pancreatitis.

Methods: This prospective, randomized, placebo controlled, double blind study was conducted at Victoria Hospital, Bangalore medical college

and Research Institute, Bangalore. Fifty adult subjects, aged 18 to 60 years, with acute pancreatitis and elevated serum C–reactive protein (CRP)

levels, were included in the study. APACHE II scoring system was employed to classify the subjects into mild (score <8) and severe pancreatitis

(score > or = 8). Standard care was given to all subjects as per the treating physician‘s protocol. Eligible subjects were randomized to receive

intravenous infusion of 200,000 IU ulinastatin or placebo in 100 mL of 0.9% saline given over one hour every 12 hours for 5 days.

Results: Pancreatitis was due to alcohol intake in a majority of subjects. Baseline characteristics were similar between the ulinastatin and placebo

groups. Efficacy was evaluated in subjects who had received at least 3 days (6 doses) of ulinastatin / placebo. A total of nine deaths were observed in

the severe pancreatitis group, two in the Ulinastatin group and seven in the placebo group, the difference was found to be statistically significant.

The number of organ dysfunctions were also considerably higher in the placebo group and was also found to be statistically significant. The mean

hospital stay was marginally more in the placebo group and the difference was not statistically significant.

Conclusions: The use of intravenous Ulinastatin in cases of severe pancreatitis was found to significantly reduce mortality and new onset organ

dysfunction.