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

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Drug: Placebo group; Drug: Omeprazole

• Registration Number: NCT03388463
• Lead Sponsor: Menoufia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-05-11
• Primary Completion: 2017-08-14
• Study Completion: 2017-09-17
• Status Verified: 2017-12
• Study First Submitted: 2017-12-24
• Study First Submitted QC: 2017-12-24
• Last Update Submitted: 2017-12-24
• Study First Posted: 2018-01-03
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo group	Patients received intravenous omeprazole 40mg bolus dose once daily followed by normal saline infusion.
Omeprazole group	Omeprazole	Patients received intravenous bolus of 80 mg omeprazole followed by 8mg/h infusion for the whole period of ICU stay.

Primary Outcome Measures

Name	Time	Method
Significant upper gastrointestinal bleeding	20 days during ICU stay.	Vomiting of fresh blood, melena, or haematemesis.