Single Dose Omeprazole Versus High Dose in High-risk Critically Ill Patients.
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|ClinicalTrials.gov Identifier: NCT03388463|
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Information provided by (Responsible Party):
Dr Ezzeldin Ibrahim, Menoufia University
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.
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Drug: Omeprazole Drug: Placebo group||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effectiveness of Standard Single Dose Omeprazole Versus High Dose Continuous Infusion in High-risk Critically Ill Patients.|
|Actual Study Start Date :||May 11, 2016|
|Actual Primary Completion Date :||August 14, 2017|
|Actual Study Completion Date :||September 17, 2017|
Active Comparator: Omeprazole group
Patients received intravenous bolus of 80 mg omeprazole followed by 8mg/h infusion for the whole period of ICU stay.
Omeprazole 80 mg continues infusion
Other Name: Omeprazole continues infusion
Placebo Comparator: Placebo group
Patients received intravenous omeprazole 40mg bolus dose once daily followed by normal saline infusion.
Drug: Placebo group
Omeprazole 40 mg single daily dose.
Other Name: Placebo for infusion
Primary Outcome Measures :
- Significant upper gastrointestinal bleeding [ Time Frame: 20 days during ICU stay. ]Vomiting of fresh blood, melena, or haematemesis.
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