Validating a Delirium Prediction Model for Critically Ill... | NCT00961389

Studies
Validating a Delirium Prediction Model for Critically Ill Patients

NCT00961389

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Oct 27, 2009Estimated

Enrollment

650Estimated

Phase

Not provided

Conditions

Delirium

Interventions

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Sep 2009Estimated

Completion Date

Oct 2009Estimated

First Submitted Date

Aug 17, 2009

First Submission Date that Met QC Criteria

Aug 18, 2009

First Posted Date

Aug 19, 2009Estimated

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

Oct 26, 2009

Last Update Posted Date

Oct 27, 2009Estimated

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

The objective of this study is to determine the incidence of delirium in adults patients who are admitted at the critical care unit of a Dutch University Hospital with the mapping of relevant delirium risk factors The primary aim is to validate the investigators' developed delirium prediction model for critical care patients.

A secondary aim is to find differences between delirious patients and non-delirious patients on different aspects of diagnostics, treatment and care, outcome, length of stay, and inflammation.

According to Dutch law, the need to obtain informed consent was waived by the Committee on Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

650Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
delirious patients		minimal any positive CAM-ICU score during ICU admission
non-delirious patients		without any positive CAM-ICU score during ICU admission

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
delirium		during admission at the critical care

Secondary Outcomes

Measure	Description	Time Frame
markers of inflammation		within 24 hours of delirium diagnosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all adult patients (18 years and older) admitted at the critical care unit of our hospital

Exclusion Criteria:

admitted < 12 hours on ICU
not able to understand Dutch
patients with serious hearing and visibility disabilities
mentally retarded patients
patients suffering from receptive aphasia
delirious before admission

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

tertiary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mark van den Boogaard, MSc, R< CCRN	Contact	+31243655618		m.vandenboogaard@ic.umcn.nl
Peter Pickkers, MD, PhD	Contact	+31243615363		p.pickkers@ic.umcn.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Nijmegen Medical Centre, Critical Care	Recruiting	Nijmegen	Gelderland		Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22323509	Derived	van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.

Type	Date	Date Unknown
Release	May 26, 2014
Reset	Jun 29, 2014
Release	Nov 13, 2014
Reset	Nov 20, 2014
Release	Nov 21, 2014
Reset	Dec 2, 2014

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 26, 2014			Jun 29, 2014
Nov 13, 2014

ID	Term
D003693	Delirium
D007249	Inflammation

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases