NCT02296866

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

2 months

First QC Date

November 18, 2014

Last Update Submit

December 26, 2014

Conditions

Emergency SurgeryFull Stomach

Outcome Measures

Primary Outcomes (1)

  • ultrasonographic measurement of antral area

    30 minutes and immediately before erythromycin infusion, and 30, 60 and 90 min after the start of erythromycin infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all trauma patients with a full stomach, undegoing emergency surgery

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Edouard Herriot

Lyon, 69003, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

September 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

FR(1)