DeliriumNCT01291368
Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care
An observational study of Delirium and Stress Disorders, Post-Traumatic, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The aim of this study is to investigate if sedation of Intensive Care Unit (ICU) patients influences the development of delirium during their ICU stay and if incidences of delirium have an impact on the development of Post-traumatic Stress-Disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Stress Disorders, Post-Traumatic
- How many people
- 248 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2009to Feb 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients at the ICUs ITA and 600 at Århus Sygehus, Denmark from September 2009 and at Hillerød Intensive, Denmark from 15th October 2010 to 1st October 2011.
Who may be able to join
- ICU-stay > 48 hours
Who cannot join
- Severe brain trauma
- Non-Danish-speaking
- Age < 18 years
- Death (only hypothesis 2 and 3 in the study)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital, Århus Sygehus
Aarhus, Aarhus, 8000
Anæstesiologisk Afdeling, . Hillerød Hospital
Hillerød, Hillerød, 3400
About this study
Official title: Does Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care?
The aim of this study is to investigate if sedation of Intensive Care Unit (ICU) patients influences the development of delirium during their ICU stay and if incidences of delirium have an impact on the development of Post-traumatic Stress-Disorder (PTSD).
Hypothesis 1:
Patients who are minimally sedated, remember staying in ICU and experiences fewer episodes of delirium than patients that are heavily sedated
Hypothesis 2:
Former delirious patients are more likely to develop PTSD
Hypothesis 3:
Delirium decreases health-related quality (HRQoL) of life after discharge
Read the detailed description
Background:
It is known that ICU patients that experience delirium have longer hospital stay, higher mortality and morbidity. Other studies indicate that PTSD, dementia or depression may emerge after discharge from hospital.
Methods according to hypothesis 1:
During ICU stay: Measure sedation level \& delirium. First follow-up 1-2 weeks after ICU: Memories
Analyses:
Data will be analyzed descriptive via EPIDATA and Stata Delirium is endpoint, defined as CAM-ICU positive. Sedation level is exposure variable.
Confounders: priory antipsychotic treatment or hypertension,glasses or hearing aids,alcohol and tobacco abuse,degree of illness,age and sex.
Correlation between sedation level and memories will be calculated.
Methods according to hypothesis 2:
Screening for: PTSD, Depression, Anxiety
Analyses:
PTSD is endpoint, and delirium is the exposure variable. Main confounders: Anxiety and Depression Mean of PTSD will be calculated with Confidence Interval to test any difference between experienced delirium or not.
Methods according to hypothesis 3:
Method:Health-related quality of life is endpoint, Activities of daily living (ADL), Memories, and a Script Test (only after 2 month)
Analyses:
Mean of HRQoL will be calculated with Confidence Interval to test any difference between experienced delirium or not.
Confounders: Diary and/or Follow up
- Conditions
- Delirium, Stress Disorders, Post-Traumatic
- Keywords
- Sedation, Delirium, PTSD, Depression, Anxiety, HRQoL, CAM-ICU, RASS, SF-36, ICU-memory tool, Antipsychotic Agents, Mobilization, ICU-nursing, ICU, intensive care, critical care, critical care nursing
- Medical subject headings
- Delirium, Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation level and Delirium
Sedation assessed with RASS and delirium assessed with the CAM-ICU by the nurses at the ICU
Measured: At least twice a day while in the ICU
Secondary outcomes (2)
Post Traumatic Stress Disorder
Minimum 250 patients who accept phone interviews are called twice (after 2 and 6 month) to answer these questionnaires:
- Intensive Care Unit - memory tool
- Harvard Trauma Questionnaire (HTQ)
- Major Depression Inventory (MDI)
- State-Trait Anxiety Inventory Form Y (STAI)
Measured: 2 and 6 month after ICU-discharge
Health-related quality of life
Minimum 250 patients who accept phone interviews are called twice (after 2 and 6 month) to answer the questionnaires:
- Activities of daily living (ADL)
- Short-form 36
- Script Test (only after 2 month)
Measured: 2 and 6 month after ICU-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startSep 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Responsible party
- Sponsor
- Investigators
- Else Tønnesen, MD Professor, Study chair, Dept. of Anasthesia, Aarhus Universtyhospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291368
- Sponsor's protocol ID
- 1-16-02-50-09
- Status last verified
- Oct 2012
- First submitted
- 20 Jan 2011
- Last updated
- 22 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care?
- ClinicalTrials.gov ID
- NCT01291368
- Acronym / sponsor ID
- 1-16-02-50-09
- Conditions
- Delirium, Stress Disorders, Post-Traumatic
- Keywords
- Sedation, Delirium, PTSD, Depression, Anxiety, HRQoL, CAM-ICU, RASS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Study start
- Sep 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Feb 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.
The aim of this study is to investigate if sedation of Intensive Care Unit (ICU) patients influences the development of delirium during their ICU stay and if incidences of delirium have an impact on the development of Post-traumatic Stress-Disorder (PTSD).
Hypothesis 1:
Patients who are minimally sedated, remember staying in ICU and experiences fewer episodes of delirium than patients that are heavily sedated
Hypothesis 2:
Former delirious patients are more likely to develop PTSD
Hypothesis 3:
Delirium decreases health-related quality (HRQoL) of life after discharge
Detailed description
Background:
It is known that ICU patients that experience delirium have longer hospital stay, higher mortality and morbidity. Other studies indicate that PTSD, dementia or depression may emerge after discharge from hospital.
Methods according to hypothesis 1:
During ICU stay: Measure sedation level \& delirium. First follow-up 1-2 weeks after ICU: Memories
Analyses:
Data will be analyzed descriptive via EPIDATA and Stata Delirium is endpoint, defined as CAM-ICU positive. Sedation level is exposure variable.
Confounders: priory antipsychotic treatment or hypertension,glasses or hearing aids,alcohol and tobacco abuse,degree of illness,age and sex.
Correlation between sedation level and memories will be calculated.
Methods according to hypothesis 2:
Screening for: PTSD, Depression, Anxiety
Analyses:
PTSD is endpoint, and delirium is the exposure variable. Main confounders: Anxiety and Depression Mean of PTSD will be calculated with Confidence Interval to test any difference between experienced delirium or not.
Methods according to hypothesis 3:
Method:Health-related quality of life is endpoint, Activities of daily living (ADL), Memories, and a Script Test (only after 2 month)
Analyses:
Mean of HRQoL will be calculated with Confidence Interval to test any difference between experienced delirium or not.
Confounders: Diary and/or Follow up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients at the ICUs ITA and 600 at Århus Sygehus, Denmark from September 2009 and at Hillerød Intensive, Denmark from 15th October 2010 to 1st October 2011.
Key inclusion criteria (1 listed)
- ICU-stay > 48 hours
Key exclusion criteria (4 listed)
- Severe brain trauma
- Non-Danish-speaking
- Age < 18 years
- Death (only hypothesis 2 and 3 in the study)
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
Sedation level and Delirium
Time frame: At least twice a day while in the ICU
Sedation assessed with RASS and delirium assessed with the CAM-ICU by the nurses at the ICU
2 secondary outcomes
Post Traumatic Stress Disorder
Time frame: 2 and 6 month after ICU-discharge
Health-related quality of life
Time frame: 2 and 6 month after ICU-discharge
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 22 Oct 2012.
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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.
Else Tønnesen, MD Professor study chair
Dept. of Anasthesia, Aarhus Universtyhospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Stress Disorders, Post-Traumatic, run by University of Aarhus at 2 sites in Denmark.
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 1 inclusion and 4 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 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Sedation level and Delirium (time frame: At least twice a day while in the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2012.