Single Dose Omeprazole Versus High Dose in High-risk Critically Ill Patients.

Study Overview
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Brief Summary
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Upper gastrointestinal (GIT) bleeding is common in high risk critically ill patients. Hyperacidity has been identified as one of the main reasons for bleeding.1 2 Antacids with different treatment modalities have been studied to establish the best regimen for prophylaxis against bleeding.3 4 Proton pump inhibitors (PPI) are the most common drugs used in the medical field as antacids. The present study was carried out to investigate the beneficial effects of high dose omeprazole versus standard low dose as a prophylaxis against upper GIT bleeding in high risk critically ill patients.

Detailed Description
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A hundred and ten high risk critically ill patients were divided into two groups, fify five patients each. Group A received intravenous (IV) omeprazole 40mg bolus dose once daily followed by normal saline infusion. Group B received IV bolus of 80 mg omeprazole followed by 8mg/h infusion. The treatment was for the whole period of ICU stay. Gastric pH, residual gastric volume, signs of significant upper GIT bleeding, ICU stay Hb, number of ventilator free days, ICU stay haemoglobin (Hb), number of red cell units transfused in ICU, ICU stay, and numbers of ICU survivors were recorded.

Official Title
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The Effectiveness of Standard Single Dose Omeprazole Versus High Dose Continuous Infusion in High-risk Critically Ill Patients.

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: Omeprazole
* Drug: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanically ventilated patients were identified as high risk patients. Patients with nasogastric tube inserted as part of their medical care were included in the study. Exclusion Criteria: Patients admitted because of upper gastrointestinal bleeding, patients who were not scheduled for early enteral nutrition during the first 24 hours of intensive care unit (ICU) admission, patients with bleeding disorders, renal replacement therapy, history of gastric ulcer, gastric surgery, and the use of gastric antacids before ICU admission.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omeprazole group<br>Patients received intravenous bolus of 80 mg omeprazole followed by 8mg/h infusion for the whole period of ICU stay. | Drug: Omeprazole<br>* Omeprazole 80 mg continues infusion<br>* Other names: Omeprazole continues infusion;|
| Placebo Comparator: Placebo group<br>Patients received intravenous omeprazole 40mg bolus dose once daily followed by normal saline infusion. | Drug: Placebo group<br>* Omeprazole 40 mg single daily dose.<br>* Other names: Placebo for infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant upper gastrointestinal bleeding | Vomiting of fresh blood, melena, or haematemesis. | 20 days during ICU stay. |