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

NCT00633035 | Completed Phase 4 DMC

• 1 other identifier: FEMH-94-C-016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcer

Keywords

ulcer; esomeprazole; famotidine; Neurosurgery

Outcome Measures

Primary Outcomes (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

  7 days within the period of prophylactic medication use

Secondary Outcomes (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

  7 days within the period of prophyactic medication use

Study Arms (2)

1

ACTIVE COMPARATOR

oral esomeprazole tablet dissolved in water given through NG tube

Drug: esomeprazole 40 mg

2

ACTIVE COMPARATOR

intravenous famotidine injection

Drug: famotidine 20 mg

Interventions

esomeprazole 40 mg DRUG

esomeprazole 40 mg po given for 7 days

Also known as: Nexium

1

famotidine 20 mg DRUG

famotidine 20 mg intravenous bolus q12h for 7 days

Also known as: gaster

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, 22050, Taiwan

Location

Related Publications (15)

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  PMID: 8284001 BACKGROUND

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  PMID: 9934901 BACKGROUND

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  PMID: 8544272 BACKGROUND

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  PMID: 15061430 BACKGROUND

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  PMID: 15143910 BACKGROUND

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  PMID: 9339962 BACKGROUND

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  PMID: 2891032 BACKGROUND

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  PMID: 8431119 BACKGROUND

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  PMID: 9201091 BACKGROUND

• Lasky MR, Metzler MH, Phillips JO. A prospective study of omeprazole suspension to prevent clinically significant gastrointestinal bleeding from stress ulcers in mechanically ventilated trauma patients. J Trauma. 1998 Mar;44(3):527-33. doi: 10.1097/00005373-199803000-00020.

  PMID: 9529184 BACKGROUND

• Daley RJ, Rebuck JA, Welage LS, Rogers FB. Prevention of stress ulceration: current trends in critical care. Crit Care Med. 2004 Oct;32(10):2008-13. doi: 10.1097/01.ccm.0000142398.73762.20.

  PMID: 15483408 BACKGROUND

• Lu WY, Rhoney DH, Boling WB, Johnson JD, Smith TC. A review of stress ulcer prophylaxis in the neurosurgical intensive care unit. Neurosurgery. 1997 Aug;41(2):416-25; discussion 425-6. doi: 10.1097/00006123-199708000-00017.

  PMID: 9257310 BACKGROUND

• Martin LF, Booth FV, Karlstadt RG, Silverstein JH, Jacobs DM, Hampsey J, Bowman SC, D'Ambrosio CA, Rockhold FW. Continuous intravenous cimetidine decreases stress-related upper gastrointestinal hemorrhage without promoting pneumonia. Crit Care Med. 1993 Jan;21(1):19-30. doi: 10.1097/00003246-199301000-00009.

  PMID: 8420726 BACKGROUND

• Hatton J, Lu WY, Rhoney DH, Tibbs PA, Dempsey RJ, Young B. A step-wise protocol for stress ulcer prophylaxis in the neurosurgical intensive care unit. Surg Neurol. 1996 Nov;46(5):493-9. doi: 10.1016/s0090-3019(96)00245-5.

  PMID: 8874553 BACKGROUND

MeSH Terms

Conditions

Ulcer

Interventions

Esomeprazole; Famotidine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

Study Officials

• Tzong-Hsi Lee, M.D.

  Far Eastern Memorial Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Division of Hepatology and Gastroenterology

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 11, 2008
• Study Start: September 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

TW (1)