NCT03405038

Brief Summary

Catheter colonization, catheter-associated infection and catheter-associated bacteremia are a major challenge for resuscitation unit. This study wishes to explore the impact of the central venous catheter colonization on the ARDS patient with and without prone position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

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

November 2, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

January 12, 2018

Last Update Submit

February 1, 2019

Conditions

ARDS, HumanCatheter Infection

Outcome Measures

Primary Outcomes (1)

  • Impact of the prone position

    Incidence rate of the bacterial colonization at least one catheter during the stay in resuscitation unit

    Day 1

Secondary Outcomes (1)

  • Infection associated factors

    Day 1

Eligibility Criteria

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

ARDS patients with a central venous catheter placed or not into prone position

You may qualify if:

  • Hospitalized patient in the reanimation unit of the CHR Metz-Thionville or the CHRU Nancy between january 2014 and december 2015
  • Patient with an acute respiratory distress syndrome, moderate or severe
  • With a central venous catheter
  • With or without prone position during the stay

You may not qualify if:

  • Minor patient
  • Absence of information on central venous catheter bacteriology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz Thionville

Metz, 57085, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 19, 2018

Study Start

November 2, 2017

Primary Completion

June 4, 2018

Study Completion

January 1, 2019

Last Updated

February 4, 2019

Record last verified: 2018-01

Locations

FR(1)