Assessment of Prokinetic Effects of Erythromycin in Emerg... | NCT02296866

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

NCT02296866

Sponsor

Lionel Bouvet

Status

Completed

Last Update Posted

Dec 30, 2014Estimated

Enrollment

28Actual

Phase

Not provided

Conditions

Emergency Surgery
Full Stomach

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Nov 18, 2014

First Submission Date that Met QC Criteria

Nov 19, 2014

First Posted Date

Nov 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ultrasonographic measurement of antral area		30 minutes and immediately before erythromycin infusion, and 30, 60 and 90 min after the start of erythromycin infusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

all trauma patients with a full stomach, undegoing emergency surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Edouard Herriot		Lyon		69003	France