Clinical trial NCT01291368: Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care
Official title: Does Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care?
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Novo Nordic Foundation
First posted: 2011-02-08
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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).

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

Eligibility criteria: Inclusion Criteria:

* ICU-stay \> 48 hours

Exclusion Criteria:

* Severe brain trauma
* Non-Danish-speaking
* Age \< 18 years
* Death (only hypothesis 2 and 3 in the study)

Primary outcomes:
measure: Sedation level and Delirium
timeFrame: At least twice a day while in the ICU
Secondary outcomes:
measure: Post Traumatic Stress Disorder
timeFrame: 2 and 6 month after ICU-discharge
measure: Health-related quality of life
timeFrame: 2 and 6 month after ICU-discharge
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Århus Sygehus
city: Hillerød
country: Denmark
facility: Anæstesiologisk Afdeling, . Hillerød Hospital
Study officials:
affiliation: Dept. of Anasthesia, Aarhus Universtyhospital
name: Else Tønnesen, MD Professor
role: STUDY_CHAIR
References: