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

M

Menoufia University

Status

Completed

Conditions

Critical Illness

Treatments

Drug: Placebo group
Drug: Omeprazole

Study type

Interventional

Funder types

Other

Identifiers

NCT03388463
MenoufiaU2016/2ICU

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

110 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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