Emergency SurgeryNCT02296866
Assessment of Prokinetic Effects of Erythromycin in Emergency Patients With a Full Stomach
An observational study of Emergency Surgery and Full Stomach, run by Lionel Bouvet at 1 site in France.
Trial summary
The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes in non-fasting patients undergoing emergency trauma surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Surgery, Full Stomach
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Nov 2014
- Phase
- Observational
- 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
Study population: all trauma patients with a full stomach, undegoing emergency surgery
Who may be able to join
- Emergency surgery for trauma
- ASA 1 and 2 patients
- Full stomach (antral area > 550 mm²)
- Adult patients
Who cannot join
- No contraindication to erythromycin
- Extreme emergency surgery (time frame < 90 min between arrival in the service and the start of the surgery)
- gastroparesis or pathology associated with gastroparesis
Trial locations and contacts
1 site in 1 country.
About this study
The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes in non-fasting patients undergoing emergency trauma surgery.
- Conditions
- Emergency Surgery, Full Stomach
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasonographic measurement of antral area
Measured: 30 minutes and immediately before erythromycin infusion, and 30, 60 and 90 min after the start of erythromycin infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lionel Bouvet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lionel Bouvet, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296866
- Sponsor's protocol ID
- 2013-A01257-38
- Status last verified
- Dec 2014
- First submitted
- 18 Nov 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prokinetic Effects of Erythromycin in Emergency Patients With a Full Stomach
- ClinicalTrials.gov ID
- NCT02296866
- Acronym / sponsor ID
- 2013-A01257-38
- Conditions
- Emergency Surgery, Full Stomach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Lionel BouvetUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Nov 2014 (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.
The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes in non-fasting patients undergoing emergency trauma surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all trauma patients with a full stomach, undegoing emergency surgery
Key inclusion criteria (4 listed)
- Emergency surgery for trauma
- ASA 1 and 2 patients
- Full stomach (antral area > 550 mm²)
- Adult patients
Key exclusion criteria (3 listed)
- No contraindication to erythromycin
- Extreme emergency surgery (time frame < 90 min between arrival in the service and the start of the surgery)
- gastroparesis or pathology associated with gastroparesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ultrasonographic measurement of antral area
Time frame: 30 minutes and immediately before erythromycin infusion, and 30, 60 and 90 min after the start of erythromycin infusion
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 30 Dec 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Surgery and Full Stomach, run by Lionel Bouvet 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 4 inclusion and 3 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 30 Dec 2014. 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.
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?
ultrasonographic measurement of antral area (time frame: 30 minutes and immediately before erythromycin infusion, and 30, 60 and 90 min after the start of erythromycin infusion). 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 30 Dec 2014.