Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit
Condition: Ulcer
MeSH terms: Ulcer
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      1. patients: the patients receiving neurosurgery and admitted to intensiv care unit within
           24 hours. They are enrolled after well explanation and giving written consdent. Those
           are less than 18 y/o, pregnant, not suitable for NG feeding, already having GI bleeding,
           are excluded

        2. grouping & intervention: The patients are randomized to 2 groups. 1st group:receiving
           esomeprazole 40 mg qd via NG; 2nd group: receiving famotidine 20 mg iv bolus q12h. These
           medication are used for 7 days. Estimated enrolled number is 60 for each group

        3. monitoring: Glasgow coma scale , APACHE II score at baseline, CBC、CXR at basleine and
           qod, stool OB q3d，NG drainage、sputum、 stool character, ICU routine （TPR, BP）, ICU
           admitted day, 30 day mortality rate. UGI endoscopy arranged according judgement of
           attending doctors

        4. end points: overt UGI bleeding（tarry stool,hematemesis、coffee ground substance from NG
           more than 60 ml, Hb decrease more than 2g/dl and endoscopic proof of bleeder）.
           ventilator associated pneumonia: new onset and persisted hazziness in CXR, combined with
           fever, leucocytosis and positive sputum smear finding.

        5. statistics: the prevalence of overt bleeding and ventilator associated pneumonia is
           examined by Fisher's exact test, the demongraphic data and disease severity data are
           examined by student's t test or Chi-square test。
    

Intervention name(s): esomeprazole 40 mg; famotidine 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): esomeprazole 40 mg po given for 7 days; famotidine 20 mg intravenous bolus q12h for 7 days
Other intervention name(s): Nexium; gaster
Intervention MeSH terms: Esomeprazole; Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ulcer; esomeprazole; famotidine; Neurosurgery