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: August 9, 2013
Last verified: August 2013
  Purpose

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


Condition
Delirium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1002
Study Start Date: January 2011
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Critically ill patients
Patients staying in the ICU on the 25th of January

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

ICU patients

Criteria

Inclusion Criteria:

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

No exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278524

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Claudia Spies
European Society of Intensive Care Medicine
Investigators
Study Director: Claudia Spies, MD Charité - Universitaetsmedizin Berlin
  More Information

Additional Information:
Survey  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Claudia Spies, Prof. Dr. C. Spies, MD, Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01278524     History of Changes
Other Study ID Numbers: IMPROVE-ICU
Study First Received: January 18, 2011
Last Updated: August 9, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Delirium
Analgosedation
ICU
Pain
Implementation

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014