Team Elements Associated With Mortality in Intensive Care | NCT03162146

Studies
Team Elements Associated With Mortality in Intensive Care

NCT03162146

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

May 22, 2017Actual

Enrollment

43,378Estimated

Phase

Not provided

Conditions

Intensive Care Unit Stay
Death

Interventions

Deaths in intensive care unit

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

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2017Estimated

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

May 17, 2017

First Submission Date that Met QC Criteria

May 19, 2017

First Posted Date

May 22, 2017Actual

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

May 19, 2017

Last Update Posted Date

May 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The individual characteristics and interactions of health care workers in intensive care units may influence patient safety. This study aims to quantify the influence of team familiarity among the members of medical and nursing staffs on risk of patient death.

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

43,378Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient admitted to intensive care unit		All patients requiring intensive care unit stay	Other: Deaths in intensive care unit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deaths in intensive care unit	Other	Assessment of the influence of team familiarity among the members of medical and nursing staffs on risk of patient death	Patient admitted to intensive care unit

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient mortality	Mortality with stratification on patients for whom a forego life-sustaining therapy decision was made	At the time of intensive care unit discharge up to a maximum of 6 years since admission

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who were admitted to 9 French intensive care units from January 1st 2011 to December 31st 2016

Exclusion Criteria:

Patients admitted in pediatrics intensive care units and in specialized burns units

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

Patient admitted to intensive care unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Claude GUERIN, MD, PhD	Contact	04 26 10 94 18	+33	claude.guerin@chu-lyon.fr
Antoine DUCLOS, MD, PhD	Contact	04 72 11 51 66	+33	antoine.duclos@chu-lyon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Réanimation médicale, Hôpital de la Croix Rousse		Lyon		69317	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000071459	Death Domain
D007362	Intensive Care Units

Ancestor Terms

ID	Term
D000071458	Death Domain Superfamily
D054730	Protein Interaction Domains and Motifs
D000072417	Protein Domains
D000072416	Protein Structural Elements

Browse Leaves

Not provided

Browse Branches

Not provided