We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278524
First Posted: January 19, 2011
Last Update Posted: August 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
European Society of Intensive Care Medicine
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
  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 Claudia Spies, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Implementation rate of routine delirium assessment [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Point prevalence of ICU delirium [ Time Frame: 24 hours ]
  • Methodology of delirium assessment (e.g. type of score, frequency of evaluation) [ Time Frame: 24 hours ]
  • Non-pharmacological treatment-/prevention strategies [ Time Frame: 24 hours ]
  • Drugs used for delirium treatment [ Time Frame: 24 hours ]
  • Sedation practices (e.g. scales, daily sedation goals, SBT - spontaneous breathing trials, SAT - spontaneous awakening trials) [ Time Frame: 24 hours ]
  • Analgesia regimes (e.g. scales) [ Time Frame: 24 hours ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 18, 2011
First Posted: January 19, 2011
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Claudia Spies, 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
Neurocognitive Disorders
Mental Disorders