Intermittent intravenous pantoprazole and continuous cimetidine infusion: Effect on gastric pH control in critically ill patients at risk of developing stress-related mucosal disease

Background: This study aimed to assess intermittent intravenous (IV) pantoprazole for control of gastric acid and the possible prevention of upper gastrointestinal (UGI) bleeding in intensive care units (ICU) patients. Methods:. This was a multicenter, randomized, open-label, dose-ranging pilot study of IV pantoprazole (40 mg q24 hour; 40 mg q12 hour; 80 mg q24 hour; 80 mg q12 hour; 80 mg q8 hour) or continuously infused cimetidine (300 mg bolus; 50 mg/h) in patients at risk for UGI bleeding. The primary endpoint was percent time gastric pH >= 4.0. UGI bleeding and pneumonia were measured as secondary endpoints. Results: Two hundred two ICU patients were randomized. Gastric pH was well controlled by all treatments. Gastric pH control improved from day 1 to day 2 in all pantoprazole groups, whereas there was decreased pH control in the cimetidine group. There were no cases of protocol defined UGI bleeding in any treatment group. Adverse event frequency and pneumonia incidence were similar between pantoprazole and cimetidine treated patients. Conclusions: This pilot study indicates that intermittent IV pantoprazole effectively controls gastric pH and may protect against UGI bleeding in high risk ICU patients without the development of tolerance.