(Taken from application) Severe acute pancreatitis is a systemic, hypermetabolic disease that occurs in 10% to 20% of all patients with acute pancreatitis and has a 30% to 50% mortality. This inflammatory disease, likened to states of bacterial sepsis and traumatic shock, is characterized by release of multiple cytokines and other inflammatory mediators with greatly increased caloric and nitrogen requirements. Total parenteral nutrition (TPN) has been shown to be safe and to reduce morbidity and mortality in two separate uncontrolled studies of patients with severe pancreatitis. Unfortunately, there is a significant incidence of catheter sepsis in this group of patients. Several studies have demonstrated safety of enteral feedings infused into the jejunum of patients with post operative paralytic ileus. Advantages of enteral feedings include no potential catheter sepsis, and perhaps promoting gut mucosal integrity. Enteral feedings do not have been demonstrated [sic] to be safe in small uncontrolled series of patients with mild acute pancreatitis. Unfortunately, mild pancreatitis is by definition a mild, self-limited disease that does not require nutritional support. We HYPOTHESIZE that 1 ) TPN and enteral (intrajejunal) feeding provide comparable, effective nutritional support in patients with severe acute pancreatitis. 2) Enteral feeding provides the additional benefits of less infectious complications and a shorter hospital stay in this severely ill group of patients. In order to test these HYPOTHESES, we propose a multicenter, randomized, prospective clinical trial comparing TPN to intrajejunal enteral feedings in patients with severe acute pancreatitis. Clinical outcomes measured will include: 1) the number of infectious complications and the number of hospital days 2) local complications, systemic complications, and mortality;. [sic] Endpoints will include the occurrence of hospital discharge and death. We believe this study will provide important information regarding the appropriate route of nutrition support of patients with severe acute pancreatitis.
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