Official Title: “Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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(s) in this Clinical Trial

• Drug: esomeprazole 40 mg (Nexium)
  • esomeprazole 40 mg po given for 7 days
• Drug: Fadin
  • famotidine 20 mg intravenous bolus q12h for 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • oral esomeprazole
• Active Comparator: 2
  • intravenous famotidine

Primary Measures

• UGI bleeding: hematemesis or much coffee ground substance (> 60 ml) from NG, tarry stool, decrease of Hb more than 2g/dl and endoscopic proof of bleeder
  • Time Frame: 7 days within the period of prophylactic medication use
    

Secondary Measures

• ventilator associated pneumonia: new onset and persistent hazziness in CXR 48 hours after admission to ICU, combined with fever and leucocytosis and positive sputum smear finding
  • Time Frame: 7 days within the period of prophyactic medication use
    

Inclusion Criteria:

• Within 24 hours of admission to Neurosurgical ICU after neurosurgery with ventilator support

Exclusion Criteria:

• Less than 18 y/o;
• Pregnancy;
• Not suitable for medication from NG route,
• Had GI bleeding at admission to ICU

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Far Eastern Memorial Hospital

Overall Clinical Trial Officials and Contacts

Tzong-Hsi Lee, M.D. Principal Investigator Far Eastern Memorial Hospital, Taipei, Taiwan  

Overall Contact: Tzong-Hsi Lee, M.D. 886-2-89667000 thleekimo@yahoo.com.tw

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00633035

Study ID Number: FEMH-94-C-016

ClinicalTrials.gov Identifier: NCT00633035

Health Authority: Taiwan: Department of Health