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CompletedNCT03388463Updated Jan 3, 2018

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

An interventional study of Omeprazole and Placebo group in Critical Illness, sponsored by Menoufia University. Completed. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-03.

Sponsored by Menoufia University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled May 2016, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Critical Illness

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03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's enrollment of 110 is above the median of 90 across 926 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo group

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

    Drug: Placebo group

Interventions

  • DrugOmeprazole

    Omeprazole 80 mg continues infusion

    Also known as: Omeprazole continues infusion

  • DrugPlacebo group

    Omeprazole 40 mg single daily dose.

    Also known as: Placebo for infusion

06

What researchers measure

Primary outcomes

  1. Significant upper gastrointestinal bleeding

    Vomiting of fresh blood, melena, or haematemesis.

    Time frame: 20 days during ICU stay.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2016 to primary completion in Aug 2017, 15 months.

Of 400 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 15 months is below that.

Counting every sponsor, half of 404 studies reached it within 21 months; a quarter within 12 and three quarters within 40.

Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2017
First posted
Jan 3, 2018
StartActual
May 11, 2016
Primary completionActual
Aug 14, 2017
CompletionActual
Sep 17, 2017
Last update
Jan 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03388463
Lead sponsor
Menoufia University
Responsible party
Dr Ezzeldin Ibrahim (Assistant Professor in anaesthesia, intensive care, and pain medicine., Menoufia University) — Principal investigator
First posted
Jan 3, 2018
Start date
May 11, 2016
Primary completion
Aug 14, 2017
Completion
Sep 17, 2017
Last update
Jan 3, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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