A multicentre feasibility study evaluating stress ulcer prophylaxis using hospital-based registry data

Background: It is unclear whether histamine-2 receptor blockers (H2RBs) or proton pump inhibitors (PPIs) are preferred for stress ulcer prophylaxis (SUP) in intensive care unit patients. Suitably powered comparative effectiveness trials are warranted. Objective: To establish the feasibility of collecting process-of-care and outcome data relevant to a proposed interventional trial of SUP using existing databases. Design, setting and participants: A retrospective cohort study conducted in seven Australia and New Zealand tertiary ICUs, including all patients >= 18 years admitted between 1 January 2011 and 31 December 2012. Main outcome measures: Doses of dispensed PPIs and H2RBs, upper gastrointestinal bleeding events, upper respiratory tract colonisation with pathogenic bacteria, Clostridium difficile infections and inhospital mortality. Results: All sites were able to contribute to the study and investigators reported that data were generally easy to obtain. A median dose/ICU of 477 g of PPIs (interquartile range [IQR], 430.5-865 g), and 408.5 g (IQR, 109-1630.2 g) of H2RBs, were dispensed over the 2 years of the study. The median proportion of patients/ICU with upper GI bleeding complicating admission was 1.4% (IQR, 0.3%-1.8%). Colonisation of the respiratory tract with gram-negative bacteria occurred in a median of 7.1% of patients/ICU (IQR, 6.3%-14.1%). Pseudomembranous colitis occurred in hospital in a median of 1.4% of patients (IQR, 0.9%-2%) and inhospital mortality was 10.6% (95% CI, 9.5%- 11.7%). Conclusions: It is feasible to use existing data sources to measure process-of-care and outcome data necessary for a registry-based interventional trial of SUP.