Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
Although stress ulcer is a complication that can cause mortality and morbidity in critical
patients, there is still lack of consensus about its prophylaxis. There is also few data
available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer
sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia.
Recently, proton pump inhibitors were shown to have good prophylactic effects for stress
ulcer. Esomeprazole, an isoform of omeprazole, has good acid suppression effect and the
tablets are soluble for the use of tube feeding. Our previous study showed that there was no
difference for the efficacy of stress ulcer prophylaxis between esomeprazole and sucralfate
in patients admitted to medical ICU with at least one risk factor. The prevalence of
nosocomial pneumonia was also similar.
We will enroll those patients that have received intracranial surgery and admitted to
neurosurgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7
days within 24 hours. They are randomly allocated to 2 groups. Group I: esomeprazole 40 mg qd
from NG route or orally; Group II: famotidine 20 mg iv bolus q12h. We will monitor the
following data: Glasgow coma scale, APACHE II score, CBC, CXR, stool character and OB test,
NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopy will be performed. We
define the end point as overt bleeding, death or transfer out of ICU. We will compare the
prevalence of UGI bleeding and nosocomial pneumonia in these 2 groups.