DeliriumIMPROVE-ICUNCT01278524
International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU
An observational study of Delirium, run by Claudia Spies at 1 site in Germany.
Trial summary
An anonymous international multicenter - clinical survey, one-day observational study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delirium
- How many people
- 1,002 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ICU patients
Who may be able to join
- Patients staying in the ICU on the 25th of January (one-day prevalence study)
- No exclusion Criteria:
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Berlin, State of Berlin, 13353
About this study
An anonymous international multicenter - clinical survey, one-day observational study.
Read the 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.
- Conditions
- Delirium
- Keywords
- Delirium, Analgosedation, ICU, Pain, Implementation
- Medical subject headings
- Delirium, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Patients staying in the ICU on the 25th of January |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation rate of routine delirium assessment
Measured: 24 hours
Secondary outcomes (6)
Point prevalence of ICU delirium
Measured: 24 hours
Methodology of delirium assessment (e.g. type of score, frequency of evaluation)
Measured: 24 hours
Non-pharmacological treatment-/prevention strategies
Measured: 24 hours
Drugs used for delirium treatment
Measured: 24 hours
Sedation practices (e.g. scales, daily sedation goals, SBT - spontaneous breathing trials, SAT - spontaneous awakening trials)
Measured: 24 hours
Analgesia regimes (e.g. scales)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudia Spies
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Sponsor-investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Study director, Charité - Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278524
- Sponsor's protocol ID
- IMPROVE-ICU
- Acronym
- IMPROVE-ICU
- Status last verified
- Aug 2013
- First submitted
- 18 Jan 2011
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Luetz A, Balzer F, Radtke FM, Jones C, Citerio G, Walder B, Weiss B, Wernecke KD, Spies C. Delirium, sedation and analgesia in the intensive care unit: a multinational, two-part survey among intensivists. PLoS One. 2014 Nov 14;9(11):e110935. doi: 10.1371/journal.pone.0110935. eCollection 2014.
PubMed 25398099
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU
- ClinicalTrials.gov ID
- NCT01278524
- Acronym / sponsor ID
- IMPROVE-ICU / IMPROVE-ICU
- Conditions
- Delirium
- Keywords
- Delirium, Analgosedation, ICU, Pain, Implementation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Claudia SpiesUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | –Patients staying in the ICU on the 25th of January |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (2 listed)
- Patients staying in the ICU on the 25th of January (one-day prevalence study)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implementation rate of routine delirium assessment
Time frame: 24 hours
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
- Derived from this study: PubMed 25398099Luetz A, Balzer F, Radtke FM, Jones C, Citerio G, Walder B, Weiss B, Wernecke KD, Spies C. Delirium, sedation and analgesia in the intensive care unit: a multinational, two-part survey among intensivists. PLoS One. 2014 Nov 14;9(11):e110935. doi: 10.1371/journal.pone.0110935. eCollection 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD study director
Charité - Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Claudia Spies at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation rate of routine delirium assessment (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01278524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013.