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Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT00633035
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
Tzong-Hsi Lee, Far Eastern Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Ulcer Drug: esomeprazole 40 mg Drug: famotidine 20 mg Phase 4

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。

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit
Study Start Date : September 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
oral esomeprazole tablet dissolved in water given through NG tube
Drug: esomeprazole 40 mg
esomeprazole 40 mg po given for 7 days
Other Name: Nexium

Active Comparator: 2
intravenous famotidine injection
Drug: famotidine 20 mg
famotidine 20 mg intravenous bolus q12h for 7 days
Other Name: gaster

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633035

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Far Eastern Memorial Hospital
Taipei, Taiwan, 22050
Sponsors and Collaborators
Far Eastern Memorial Hospital
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Principal Investigator: Tzong-Hsi Lee, M.D. Far Eastern Memorial Hospital, Taipei, Taiwan

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Responsible Party: Tzong-Hsi Lee, Chief of Division of Hepatology and Gastroenterology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00633035    
Other Study ID Numbers: FEMH-94-C-016
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Keywords provided by Tzong-Hsi Lee, Far Eastern Memorial Hospital:
Additional relevant MeSH terms:
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Pathologic Processes
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs