Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-26 @ 5:44 AM
Study NCT ID:
NCT01291368
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2011-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Does Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care?
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: