Post Intensive Care Syndrome | NCT02706457

Studies
Post Intensive Care Syndrome

NCT02706457

Sponsor

Frisius Medisch Centrum

Status

Completed

Last Update Posted

Apr 12, 2016Estimated

Enrollment

849Actual

Phase

Not provided

Conditions

Post Intensive Care Syndrome
Barthel Index

Interventions

Barthel index for functionality

Countries

Netherlands

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

Apr 2016

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

Oct 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Feb 16, 2016

First Submission Date that Met QC Criteria

Mar 7, 2016

First Posted Date

Mar 11, 2016Estimated

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

Apr 11, 2016

Last Update Posted Date

Apr 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Barthel Index and demographic variables of patients were collected to investigate the question whether the improvements of the functionality improves the Barthel Index over the years.

Detailed Description

idem

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

849Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cohort 2012 - 2014		all patients admitted for > 48 hours on the Intensive Care Unit in 2012, 2013 and 2014	Other: Barthel index for functionality

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Barthel index for functionality	Other	The Barthel Index for functionality is done standard in all patients after intensive care admission	cohort 2012 - 2014

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in Barthel Index	barthel index is analyzed over the years 2012 - 2014	from januari 2012 until decembre 2014

Secondary Outcomes

Measure	Description	Time Frame
Relation between Barthel Index and length of stay in ICU		from januari 2012 until decembre 2014

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years and older
length of stay longer than 48 hours

Exclusion Criteria:

no exclusion criteria if inclusion is correct

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

patients treated in Intensive Care for minimal 48 hours, during the years 2012 - 2014

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matty Koopmans, MSc	MCL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center Leeuwarden		Leeuwarden		8904 BR	Netherlands

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
C000657744	postintensive care syndrome

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided