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

December 24, 2017 updated by: Dr Ezzeldin Ibrahim, Menoufia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Placebo for infusion

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2016

Primary Completion (Actual)

August 14, 2017

Study Completion (Actual)

September 17, 2017

Study Registration Dates

First Submitted

December 24, 2017

First Submitted That Met QC Criteria

December 24, 2017

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 24, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MenoufiaU2016/2ICU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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