International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU (IMPROVE-ICU)

This study has been completed.

Sponsor:

Collaborator:

European Society of Intensive Care Medicine

Information provided by (Responsible Party):

Claudia Spies, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01278524

First received: January 18, 2011

Last updated: September 7, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 18, 2011

Last Updated Date

September 7, 2011

Start Date ^ICMJE

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Implementation rate of routine delirium assessment [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01278524 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Point prevalence of ICU delirium [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Methodology of delirium assessment (e.g. type of score, frequency of evaluation) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Non-pharmacological treatment-/prevention strategies [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Drugs used for delirium treatment [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Sedation practices (e.g. scales, daily sedation goals, SBT - spontaneous breathing trials, SAT - spontaneous awakening trials) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Analgesia regimes (e.g. scales) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Point prevalence of ICU delirium [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Methodology of delirium assessment (e.g. type of score, frequency of evaluation) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Non-pharmacological treatment-/prevention strategies [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Drugs used for delirium treatment [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Sedation practices (e.g. scales, daily sedation goals, SBT, SAT) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Analgesia regimes (e.g. scales) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU

Official Title ^ICMJE

International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU

Brief Summary

An anonymous international multicenter - clinical survey, one-day observational study.

Detailed Description

Delirium is a serious complication in postoperative and critically ill patients and is independently associated with cognitive impairment at hospital discharge and with significantly higher 6-month mortality. Furthermore, ICU delirium is associated with more days requiring mechanically ventilation, longer ICU length of stay, and longer hospital length of stay. More recently a study by Pisani and co-workers' could show an association between days of delirium and mortality; - each additional day spent in delirium is associated with a 20% increased risk of prolonged hospitalization - translating to over 10 additional days - and a 10% increased risk of death.The reported prevalence of delirium in critically ill patients ranges widely from 11% to 87%. The aim of our study is to investigate the implementation rate of routine delirium assessment in European ICUs.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

ICU patients

Condition ^ICMJE

Delirium

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Critically ill patients

Patients staying in the ICU on the 25th of January

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1002

Completion Date

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients staying in the ICU on the 25th of January (one-day prevalence study)

No exclusion Criteria:

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01278524

Other Study ID Numbers ^ICMJE

IMPROVE-ICU

Has Data Monitoring Committee

Responsible Party

Claudia Spies, Charite University, Berlin, Germany

Study Sponsor ^ICMJE

Claudia Spies

Collaborators ^ICMJE

European Society of Intensive Care Medicine

Investigators ^ICMJE

Study Director:

Claudia Spies, MD

Charité - Universitaetsmedizin Berlin

Information Provided By

Charite University, Berlin, Germany

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top