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

October 12, 2013 updated by: Tzong-Hsi Lee, Far Eastern Memorial Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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。

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 22050
        • Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Nexium
Active Comparator: 2
intravenous famotidine injection
Drug: famotidine 20 mg
famotidine 20 mg intravenous bolus q12h for 7 days
Other Names:
  • gaster

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 days within the period of prophylactic medication use

Secondary Outcome Measures

Outcome Measure
Time Frame
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
7 days within the period of prophyactic medication use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 3, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 11, 2008

Study Record Updates

Last Update Posted (Estimate)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 12, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEMH-94-C-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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