Upper Gastrointestinal BleedingPhase 3NCT00259220
HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to Endoscopy
A Phase 3 study testing erythomycin, gastric lavage alone and erythromycine and gastric lavage in people with Upper Gastrointestinal Bleeding, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Gastric lavage is usually used for gastric preparation before endoscopy in patients with upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric tube in these patients is not clearly defined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- erythomycin, gastric lavage alone and erythromycine and gastric lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2005to Aug 2008
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hematemesis or melaena
- No QT enlargement
Who cannot join
- Refusing endoscopy
- Glasgow < 15
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy
Gastric lavage is usually used for gastric preparation before endoscopy in patients with upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric tube in these patients is not clearly defined. This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid to put a gastric tube for the management of upper gastrointestinal bleeding.
Read the detailed description
Acute upper gastrointestinal haemorrhage is one of the main digestive emergencies involving hospital admission. Endoscopic examination plays a key role to determine the cause of the bleeding and to carry out a therapeutic procedure. Endoscopic performance depends on the quality of the examination that may be hampered by residual blood in the gastric cavity. Gastric lavage is usually performed to clear the stomach. However, several teams consider that it is possible to avoid putting a nasogastric tube because it is ineffective in half of the patients, disagreeable in most of them, can induce side effects and need a long time work for nurses. It could be replaced by the use of Erythromycin. There are no official recommendations in that field. Recent studies have shown that Erythromycin, a macrolide antibiotic with gastro kinetic properties can accelerate gastric emptying by inducing gastric contraction. This motilin receptor agonist could improve the gastric cleaning and the quality of endoscopic examination and decrease its duration.
This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid putting a gastric tube for the management of upper gastrointestinal bleeding. It is a prospective, controlled, randomized, multicentric study with a blind assessment of the main criteria. All patients aged more than 18 years with an acute upper gastrointestinal bleeding, defined by melena or hematemesis, managed by emergency department are enrolled. 270 patients are expected. Informed consent including for endoscopic examination and no contraindication for using Erythromycin (QT enlargement) is needed. Patients are randomized in three groups: Erythromycin alone, nasogastric tube with gastric lavage alone or both Erythromycin and nasogastric tube. Patients are followed-up until first month after bleeding. The main criteria are the visualization of the gastric tract and the other criteria are rebleeding until D 30, transfusion, gastric tube or erythromycin complications.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- erythomycin, gastric lavage alone, erythromycine and gastric lavage
- Keywords
- Bleeding, Endoscopy, Gastric tube, Erythromycin, Randomized
- Medical subject headings
- Gastrointestinal Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythomycinDrug
erythomycin
gastric lavage aloneProcedure or surgery
gastric lavage alone
erythromycine and gastric lavageProcedure or surgery
erythromycine and gastric lavage
| Study group | Role | What they receive |
|---|---|---|
| drug | Experimental | erythromycine Receives: Drug: erythomycin |
| 2 | Other | gastric lavage alone Receives: Procedure: gastric lavage alone |
| 3 | Active comparator | erythromycine and gastric lavage Receives: Procedure: erythromycine and gastric lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic yield
Measured: at the beggining of the study
Secondary outcomes (1)
Rebleeding until D 30, transfusion, gastric tube or erythromycin complications
Measured: until 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Dominique PATERON, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259220
- Sponsor's protocol ID
- P040427
- Other IDs
- AOM04093
- Status last verified
- Mar 2007
- First submitted
- 28 Nov 2005
- Last updated
- 1 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Urgency Hight Digestive Haemorrhage : Gastric Preparation for Endoscopy
- ClinicalTrials.gov ID
- NCT00259220
- Acronym / sponsor ID
- P040427
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Bleeding, Endoscopy, Gastric tube, Erythromycin, Randomized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 29 Nov 2005 (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.
Gastric lavage is usually used for gastric preparation before endoscopy in patients with upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric tube in these patients is not clearly defined. This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid to put a gastric tube for the management of upper gastrointestinal bleeding.
Detailed description
Acute upper gastrointestinal haemorrhage is one of the main digestive emergencies involving hospital admission. Endoscopic examination plays a key role to determine the cause of the bleeding and to carry out a therapeutic procedure. Endoscopic performance depends on the quality of the examination that may be hampered by residual blood in the gastric cavity. Gastric lavage is usually performed to clear the stomach. However, several teams consider that it is possible to avoid putting a nasogastric tube because it is ineffective in half of the patients, disagreeable in most of them, can induce side effects and need a long time work for nurses. It could be replaced by the use of Erythromycin. There are no official recommendations in that field. Recent studies have shown that Erythromycin, a macrolide antibiotic with gastro kinetic properties can accelerate gastric emptying by inducing gastric contraction. This motilin receptor agonist could improve the gastric cleaning and the quality of endoscopic examination and decrease its duration.
This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid putting a gastric tube for the management of upper gastrointestinal bleeding. It is a prospective, controlled, randomized, multicentric study with a blind assessment of the main criteria. All patients aged more than 18 years with an acute upper gastrointestinal bleeding, defined by melena or hematemesis, managed by emergency department are enrolled. 270 patients are expected. Informed consent including for endoscopic examination and no contraindication for using Erythromycin (QT enlargement) is needed. Patients are randomized in three groups: Erythromycin alone, nasogastric tube with gastric lavage alone or both Erythromycin and nasogastric tube. Patients are followed-up until first month after bleeding. The main criteria are the visualization of the gastric tract and the other criteria are rebleeding until D 30, transfusion, gastric tube or erythromycin complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| drug | Experimental | Drug: erythomycinerythromycine |
| 2 | Other | Procedure: gastric lavage alonegastric lavage alone |
| 3 | Active comparator | Procedure: erythromycine and gastric lavageerythromycine and gastric lavage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hematemesis or melaena
- No QT enlargement
Key exclusion criteria (2 listed)
- Refusing endoscopy
- Glasgow < 15
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 |
|---|---|---|
| erythomycinerythomycin | Drug | drug |
| gastric lavage alonegastric lavage alone | Procedure or surgery | 2 |
| erythromycine and gastric lavageerythromycine and gastric lavage | Procedure or surgery | 3 |
Primary outcome
Endoscopic yield
Time frame: at the beggining of the study
1 secondary outcome
Rebleeding until D 30, transfusion, gastric tube or erythromycin complications
Time frame: until 30 days
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 1 Oct 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.
Dominique PATERON, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing erythomycin, gastric lavage alone and erythromycine and gastric lavage in people with Upper Gastrointestinal Bleeding, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 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 1 Oct 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Endoscopic yield (time frame: at the beggining of the study). 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 1 Oct 2008.