Discontinuation of Stress Ulcer Prophylaxis After Initiation of Enteral Feeding in Severe Traumatic Brain Injury: A Prospective Multicentre Randomized Controlled Trial.

Abstract

Stress ulcer prophylaxis with proton pump inhibitors is commonly used in patients with severe traumatic brain injury, but continued use after the initiation of enteral feeding may be unnecessary and may expose patients to avoidable adverse effects. This study evaluated whether discontinuing proton pump inhibitor prophylaxis after establishment of enteral feeding increases gastrointestinal bleeding risk in patients with severe traumatic brain injury. This prospective multicentre randomized controlled trial was conducted at 2 Malaysian hospitals between January 2017 and December 2019. Patients aged 12 years or older with severe traumatic brain injury (Glasgow Coma Scale score ≤8) requiring nasogastric access received proton pump inhibitor prophylaxis while nil per os and were randomized after initiation and tolerance of enteral feeding to either enteral feeding alone or enteral feeding plus proton pump inhibitor for 5 days. The primary outcome was clinically important gastrointestinal bleeding. Secondary outcomes were overt gastrointestinal bleeding and daily mean intragastric pH. A total of 145 patients were randomized to enteral feeding alone (n=71) or enteral feeding plus proton pump inhibitor (n=74). No clinically important gastrointestinal bleeding occurred in either group. Overt gastrointestinal bleeding occurred in 3 patients (4.2%) in the enteral-feeding-alone group and 2 patients (2.7%) in the enteral-feeding-plus-proton-pump-inhibitor group (p=0.677). Daily mean intragastric pH remained above 5 throughout the 5-day study period in both groups, with no significant between-group differences (p=0.06-0.41). In patients with severe traumatic brain injury who tolerated enteral feeding, discontinuation of proton pump inhibitor prophylaxis after feeding initiation did not increase gastrointestinal bleeding risk or adversely affect intragastric pH over the 5-day study period. Enteral feeding alone may provide adequate stress ulcer prophylaxis once established, although these conclusions are limited to this early observation window and longer-term safety was not assessed.