Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care
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|ClinicalTrials.gov Identifier: NCT01291368|
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : October 22, 2012
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).
Patients who are minimally sedated, remember staying in ICU and experiences fewer episodes of delirium than patients that are heavily sedated
Former delirious patients are more likely to develop PTSD
Delirium decreases health-related quality (HRQoL) of life after discharge
|Condition or disease|
|Delirium Stress Disorders, Post-Traumatic|
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
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
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)
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 Type :||Observational|
|Actual Enrollment :||248 participants|
|Official Title:||Does Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care?|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
- 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
- Post Traumatic Stress Disorder [ Time Frame: 2 and 6 month after ICU-discharge ]
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)
- Health-related quality of life [ Time Frame: 2 and 6 month after ICU-discharge ]
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)
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): NCT01291368
|Aarhus University Hospital, Århus Sygehus|
|Aarhus, Denmark, 8000|
|Anæstesiologisk Afdeling, . Hillerød Hospital|
|Hillerød, Denmark, 3400|
|Study Chair:||Else Tønnesen, MD Professor||Dept. of Anasthesia, Aarhus Universtyhospital|