Stress ulcer prophylaxis in critically ill patients: a randomized controlled trial.
OBJECTIVE
Critically ill patients especially who require mechanical ventilation or have coagulopathy are at increased risk for stress-related gastrointestinal hemorrhage. There are conflicting data on the efficacy and complication rates of various prophylactic regimens.


METHODS
Our single-center randomized, placebo-controlled study included 287 patients with high risk for stress-related upper gastrointestinal hemorrhage (>48 h mechanical ventilation, coagulopathy). We compared 3 prophylactic regimens (proton pump inhibitor--omeprazole 40 mg i.v. once daily, n=72; H2 antagonists--famotidine 40 mg twice a day, n=71; and sucralfate 1 g every 6 hours, n=69) with placebo (n=75) in patients with trauma or after major surgery.


RESULTS
Of 287 assessable patients, clinically significant stress-related upper gastrointestinal bleeding was observed in 1%, 3%, 4%, and 1% of patients assigned to receive omeprazole, famotidine, sucralfate, and placebo, respectively (p>0.28). Bleeding developed significantly more often in patients with coagulopathy compared with the others (10% vs. 2%; p=0.006). The gastric pH (p>0.001) and gastric colonization (p<0.05) was significantly higher in the patients who received pH increasing substances when compared with the other 2 groups. Nosocomial pneumonia occurred in 11% of patients receiving omeprazole, in 10% of famotidine patients, in 9% of sucralfate patients and in 7% of controls (p>0.34). No statistically significant differences were found for days on ventilator, length of ICU stay, or mortality among all the 4 groups.


CONCLUSIONS
We could not show that omeprazole, famotidine, or sucralfate prophylaxis can affect already very low incidence of clinically important stress-related bleeding in high-risk surgical intensive care unit patients. Furthermore, our data suggested that especially gastric pH increasing medication could increase the risk for nosocomial pneumonia. Routine prophylaxis for stress-related bleeding even in high-risk patients seems not to be justified.
Kantorova
Ilona
I
Traumatological Hospital Brno, Research Center for Traumatology and Surgery, Czech Republic.
Svoboda
Petr
P
Scheer
Peter
P
Doubek
Jaroslav
J
Rehorkova
Dagmar
D
Bosakova
Hana
H
Ochmann
Jiri
J
D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001419:Bacteria / Q000302:isolation & purification; D016638:Critical Illness; D003428:Cross Infection / Q000150:complications / Q000453:epidemiology; D015738:Famotidine / Q000627:therapeutic use*; D005260:Female; D005745:Gastric Acidity Determination; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D010437:Peptic Ulcer / Q000150:complications / Q000209:etiology / Q000517:prevention & control*; D011014:Pneumonia / Q000150:complications / Q000453:epidemiology; D054328:Proton Pump Inhibitors; D013270:Stomach / Q000382:microbiology; D013312:Stress, Physiological / Q000150:complications; D013392:Sucralfate / Q000627:therapeutic use*
D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D054328:Proton Pump Inhibitors; D013392:Sucralfate; D015738:Famotidine; D009853:Omeprazole