Critically Ill PatientsPhase 4NCT00590928
Gastric pH in Critically Ill Patients
A Phase 4 study testing esomeprazole and ranitidine in people with Critically Ill Patients and Indication for Stress Ulcer Prophylaxis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critically Ill Patients, Indication for Stress Ulcer Prophylaxis
- What is being tested?
- esomeprazole and ranitidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2004to Jun 2006
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- critically ill patients
- indication for stress ulcer prophylaxis
- gastric pH < 4
Who cannot join
- gastrointestinal bleeding
- gastric pH > 4
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Medicine III, ICU
Vienna, 1090
About this study
Official title: Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.
H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is unknown, whether proton pump inhibitors are more effective in increasing gastric pH than H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.
Read the detailed description
Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.
- Being tested
- esomeprazole, ranitidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
40mg once daily
ranitidineDrug
50mg every h hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | patients with indication for stress ulcer prophylaxis and gastric pH < 4 Receives: Drug: esomeprazole |
| 2 | Active comparator | patients with indication for stress ulcer prophylaxis and gastric pH < 4 Receives: Drug: ranitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of time with gastric pH > 4
Measured: 72 hours
Secondary outcomes (4)
median gastric pH
Measured: 72 hours
incidence of gastrointestinal bleeding
Measured: 72 hours
incidence of ventilator associated pneumonia
Measured: ICU stay
the percentage of time with an gastric pH > 5
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJul 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Christian Madl, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590928
- Sponsor's protocol ID
- 13H1-CM1
- Other IDs
- ESORAN trail
- Status last verified
- Dec 2007
- First submitted
- 26 Dec 2007
- Last updated
- 11 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.
- ClinicalTrials.gov ID
- NCT00590928
- Acronym / sponsor ID
- 13H1-CM1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 11 Jan 2008 (estimated)
- 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.
H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is unknown, whether proton pump inhibitors are more effective in increasing gastric pH than H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.
Detailed description
Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: esomeprazolepatients with indication for stress ulcer prophylaxis and gastric pH < 4 |
| 2 | Active comparator | Drug: ranitidinepatients with indication for stress ulcer prophylaxis and gastric pH < 4 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- critically ill patients
- indication for stress ulcer prophylaxis
- gastric pH < 4
Key exclusion criteria (2 listed)
- gastrointestinal bleeding
- gastric pH > 4
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 |
|---|---|---|
| esomeprazole40mg once daily | Drug | 1 |
| ranitidine50mg every h hours | Drug | 2 |
Primary outcome
the percentage of time with gastric pH > 4
Time frame: 72 hours
4 secondary outcomes
median gastric pH
Time frame: 72 hours
incidence of gastrointestinal bleeding
Time frame: 72 hours
incidence of ventilator associated pneumonia
Time frame: ICU stay
the percentage of time with an gastric pH > 5
Time frame: 72 hours
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 11 Jan 2008.
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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.
Christian Madl, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing esomeprazole and ranitidine in people with Critically Ill Patients and Indication for Stress Ulcer Prophylaxis, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 2 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 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the percentage of time with gastric pH > 4 (time frame: 72 hours). 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 11 Jan 2008.