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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03388463

Enrollment

110

Registered

2018-01-03

Start date

2016-05-11

Completion date

2017-09-17

Last updated

2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

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.

Interventions

DRUGOmeprazole

Omeprazole 80 mg continues infusion

DRUGPlacebo group

Omeprazole 40 mg single daily dose.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026