Among ICU patients requiring mechanical ventilation, a strategy of stress ulcer prophylaxis with use of proton pump inhibitors vs histamine-2 receptor blockers resulted in hospital mortality rates of 18.3% vs 17.5%, respectively, a difference that did not reach the significance threshold. However, study interpretation may be limited by crossover in the use of the assigned medication.

Among 26,982 patients who were randomized, 154 opted out, and 26,828 were analyzed.

There were 26,771 patients included in the mortality analysis; 2,459 of 13,415 patients in the PPI group died at the hospital by day 90 and 2333 of 13 356 patients in the H2RB group died at the hospital by day 90.

An estimated 4.1% of patients randomized by ICU site to PPIs actually received H2RBs and an estimated 20.1% of patients randomized by ICU site to H2RBs actually received PPIs.

This study has several limitations:

• First, some patients who were excluded from the trial because of an ICU admission diagnosis of upper gastrointestinal bleeding may have actually had lower gastrointestinal bleeding and some patients who were diagnosed as having upper gastrointestinal bleeding in the ICU may have already been bleeding at the time of ICU admission.
• Second, only data from the index hospitalization were included.
• Third, because mortality data were obtained from registries, these data may contain random errors.
• Fourth, clinicians and research staff were aware of treatment assignments.

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