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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Critical Illness Drug: Omeprazole Drug: Placebo group

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Primary Completion Date : August 14, 2017
Study Completion Date : September 17, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Omeprazole group
Patients received intravenous bolus of 80 mg omeprazole followed by 8mg/h infusion for the whole period of ICU stay.
Drug: Omeprazole
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


Outcome Measures

Primary Outcome Measures :
  1. Significant upper gastrointestinal bleeding [ Time Frame: 20 days during ICU stay. ]
    Vomiting of fresh blood, melena, or haematemesis.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
More Information

Responsible Party: Dr Ezzeldin Ibrahim, Assistant Professor in anaesthesia, intensive care, and pain medicine., Menoufia University
ClinicalTrials.gov Identifier: NCT03388463     History of Changes
Other Study ID Numbers: MenoufiaU2016/2ICU
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action