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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014