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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tzong-Hsi Lee, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00633035
First received: March 3, 2008
Last updated: October 12, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Ulcer
Drug: esomeprazole 40 mg
Drug: famotidine 20 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: September 2007
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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。
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00633035

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

Publications:

Responsible Party: Tzong-Hsi Lee, Chief of Division of Hepatology and Gastroenterology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00633035     History of Changes
Other Study ID Numbers: FEMH-94-C-016
Study First Received: March 3, 2008
Last Updated: October 12, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Far Eastern Memorial Hospital:
ulcer
esomeprazole
famotidine
Neurosurgery

Additional relevant MeSH terms:
Ulcer
Pathologic Processes
Esomeprazole
Famotidine
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H2 Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014