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

Delirium Clinical Trial

— IMPROVE-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278524
• Other study ID #: IMPROVE-ICU
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: August 9, 2013
• Start date: January 2011
• Est. completion date: January 2011

Study information

• Verified date: August 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

No exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Claudia Spies	European Society of Intensive Care Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation rate of routine delirium assessment		24 hours	No
Secondary	Point prevalence of ICU delirium		24 hours	No
Secondary	Methodology of delirium assessment (e.g. type of score, frequency of evaluation)		24 hours	No
Secondary	Non-pharmacological treatment-/prevention strategies		24 hours	No
Secondary	Drugs used for delirium treatment		24 hours	No
Secondary	Sedation practices (e.g. scales, daily sedation goals, SBT - spontaneous breathing trials, SAT - spontaneous awakening trials)		24 hours	No
Secondary	Analgesia regimes (e.g. scales)		24 hours	No

External Links

•   Official Website of the Working Group Postoperative Delirium and Cognitive Dysfunction Collaborative Joint Section (WG PoDeCoD) of the European Society of Intensive Care Medicine
•   Survey