Assessment of Prokinetic Effects of Erythromycin in Emergency Patients With a Full Stomach

December 26, 2014 updated by: Lionel Bouvet
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hôpital Edouard HERRIOT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all trauma patients with a full stomach, undegoing emergency surgery

Description

Inclusion Criteria:

  • Emergency surgery for trauma
  • ASA 1 and 2 patients
  • Full stomach (antral area > 550 mm²)
  • Adult patients

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 minutes and immediately before erythromycin infusion, and 30, 60 and 90 min after the start of erythromycin infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lionel Bouvet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 26, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01257-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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