Back to results

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

Primary Purpose

Critical Illness

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Omeprazole

Placebo group

About this trial

This is an interventional prevention trial for Critical Illness

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omeprazole group

Placebo group

Arm Description

Patients received intravenous bolus of 80 mg omeprazole followed by 8mg/h infusion for the whole period of ICU stay.

Patients received intravenous omeprazole 40mg bolus dose once daily followed by normal saline infusion.

Outcomes

Primary Outcome Measures

Significant upper gastrointestinal bleeding

Vomiting of fresh blood, melena, or haematemesis.

Secondary Outcome Measures

Full Information

NCT ID

NCT03388463

First Posted

December 24, 2017

Last Updated

December 24, 2017

Sponsor

Menoufia University

1. Study Identification

Unique Protocol Identification Number

NCT03388463

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

May 11, 2016 (Actual)

Primary Completion Date

August 14, 2017 (Actual)

Study Completion Date

September 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omeprazole group

Arm Type

Active Comparator

Arm Description

Patients received intravenous bolus of 80 mg omeprazole followed by 8mg/h infusion for the whole period of ICU stay.

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Patients received intravenous omeprazole 40mg bolus dose once daily followed by normal saline infusion.

Intervention Type

Drug

Intervention Name(s)

Omeprazole

Other Intervention Name(s)

Omeprazole continues infusion

Intervention Description

Omeprazole 80 mg continues infusion

Intervention Type

Drug

Intervention Name(s)

Placebo group

Other Intervention Name(s)

Placebo for infusion

Intervention Description

Omeprazole 40 mg single daily dose.

Primary Outcome Measure Information:

Title

Significant upper gastrointestinal bleeding

Description

Vomiting of fresh blood, melena, or haematemesis.

Time Frame

20 days during ICU stay.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs