Intra Hospital Mortality Risk Factors in Patients Admitte... | NCT03835169

Studies
Intra Hospital Mortality Risk Factors in Patients Admitted to Cardiac Intensive Care Units in 2017 in France

NCT03835169

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Aug 11, 2022Actual

Enrollment

200,000Actual

Phase

Not provided

Conditions

Heart Disease
Acute Coronary Syndrome
Acute Cardiac Failure
Heart Rhythm Disorders
Valve Pathologies

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

Aug 2022

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

Jan 24, 2019Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 30, 2020Actual

First Submitted Date

Jan 24, 2019

First Submission Date that Met QC Criteria

Feb 7, 2019

First Posted Date

Feb 8, 2019Actual

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

Aug 10, 2022

Last Update Posted Date

Aug 11, 2022Actual

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

Retrospective, observational cohort study.

Objectives:

To identify intra hospital mortality risk factors in patients admitted admitted to cardiac intensive care units (CICU). The clinical main endpoint will be the observed percentage of deaths that occured during the year 2017 in french CICU.

To identify the length of stay key determiners of patients admitted in french CICU.

The study will use data from one of the french nationwide healthcare systems database (SNDS) : the national hospital discharge database (PMSI) to be precise.

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

200,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality rate	Observed percentage of deaths that occured during the year 2017 in french CICU	1 day

Secondary Outcomes

Measure	Description	Time Frame
Length of stay at a CICU	Length of stay at a CICU	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Being admitted at least one time in a french CICU in 2017
Being covered by the mandatory french national health insurance plan in 2017 without discontinuity

Exclusion criteria:

Being older than 18 years of age

Accepts Healthy Volunteers

Yes

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

Patients admitted (at least one time) in a french CICU in 2017

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François Roubille, MD, PhD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases
D054058	Acute Coronary Syndrome
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia
D014652	Vascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided