Critical IllnessNCT03388463
Single Dose Omeprazole Versus High Dose in High-risk Critically Ill Patients.
A study testing Omeprazole in people with Critical Illness, run by Menoufia University.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Omeprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2016to 17 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
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.
- Conditions
- Critical Illness
- Being tested
- Omeprazole, Placebo group
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Omeprazole continues infusion
Omeprazole 80 mg continues infusion
Placebo groupDrug
Also called Placebo for infusion
Omeprazole 40 mg single daily dose.
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole group | Active comparator | Patients received intravenous bolus of 80 mg omeprazole followed by 8mg/h infusion for the whole period of ICU stay. Receives: Drug: Omeprazole |
| Placebo group | Placebo comparator | Patients received intravenous omeprazole 40mg bolus dose once daily followed by normal saline infusion. Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant upper gastrointestinal bleeding
Vomiting of fresh blood, melena, or haematemesis.
Measured: 20 days during ICU stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start11 May 2016
- Primary completion14 Aug 2017
- Study completion17 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ezzeldin Ibrahim, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388463
- Sponsor's protocol ID
- MenoufiaU2016/2ICU
- Status last verified
- Dec 2017
- First submitted
- 24 Dec 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Standard Single Dose Omeprazole Versus High Dose Continuous Infusion in High-risk Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT03388463
- Acronym / sponsor ID
- MenoufiaU2016/2ICU
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 11 May 2016 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 17 Sep 2017 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole group | Active comparator | Drug: OmeprazolePatients received intravenous bolus of 80 mg omeprazole followed by 8mg/h infusion for the whole period of ICU stay. |
| Placebo group | Placebo comparator | Drug: Placebo groupPatients received intravenous omeprazole 40mg bolus dose once daily followed by normal saline infusion. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: Omeprazole continues infusionOmeprazole 80 mg continues infusion | Drug | Omeprazole group |
| Placebo groupAlso: Placebo for infusionOmeprazole 40 mg single daily dose. | Drug | Placebo group |
Primary outcome
Significant upper gastrointestinal bleeding
Time frame: 20 days during ICU stay.
Vomiting of fresh blood, melena, or haematemesis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Omeprazole in people with Critical Illness, run by Menoufia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant upper gastrointestinal bleeding (time frame: 20 days during ICU stay.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.