U-TRYP Solution for injection Ref.[51006] Active ingredients: Ulinastatin

1. Severe sepsis

Sepsis is defined as a systemic inflammatory response syndrome (SIRS) in the presence of, or as a result of, suspected or proven infection^1-3. Severe sepsis is defined as sepsis with one of the following features: cardiovascular organ dysfunction, acute respiratory distress syndrome (ARDS), or dysfunction of two or more⁴ organs.

Indian incidence is estimated to be about 750,000 cases per year. The most common causes for sepsis are trauma, burns, abdominal sepsis and pneumonia. Septic shock is the most common cause of mortality in the intensive care unit. Despite aggressive treatment, mortality ranges from 15% in patients with sepsis to 40-60% in patients with septic shock. There is a continuum of clinical manifestations from SIRS to sepsis to severe sepsis to septic shock to Multiple Organ Dysfunction Syndrome (MODS).

Common predisposing factors for sepsis are diabetes mellitus, concurrent anticancer drugs and corticosteroids and immunocompromised status. The best two prognostic factors are APACHE II score and number of organ dysfunctions. In a large Indian hospital based study of 5,478 ICU admissions, SIRS with organ dysfunction was present in 25%, sepsis in 52.77%, severe sepsis in 16.45% with median APACHE II score = 13 (IQR 13 to 14). The overall mortality in ICU patients was 12.08% but in patients with sepsis it was 59.26%.

2. Mild and severe acute pancreatitis

The diagnosis of mild and severe acute pancreatitis requires 2 of the following 3 features: 1) upper abdominal pain of acute onset often radiating through to the back, 2) serum amylase or lipase activity greater than 3 times normal, and 3) findings on cross-sectional abdominal imaging consistent with acute pancreatitis.¹¹ In the early phase, which lasts only a week or so, the systemic manifestations are related to the host response to the cytokine cascade, which manifests as SIRS and/or the compensatory anti-inflammatory syndrome (CARS) that can predispose to infection. When SIRS or CARS persist, organ failure sets in. The late phase of acute pancreatitis, which can persist for weeks to months, is characterized by systemic signs of ongoing inflammation, local and systemic complications, and/or by transient or persistent organ failure.¹¹

Acute pancreatitis is severe in around 20% patients, and is associated with high morbidity and mortality. Mortality is approximately 32% in the initial few days, mainly from organ failure, and later, if necrotic tissue becomes infected, 19% in the third week and 37% in the fourth.¹²