Skip to content

Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care

Does Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01291368
Enrollment
248
Registered
2011-02-08
Start date
2009-09-30
Completion date
2012-02-29
Last updated
2012-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

None listed

Sponsors

The Novo Nordic Foundation
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Sedation level and DeliriumAt least twice a day while in the ICUSedation assessed with RASS and delirium assessed with the CAM-ICU by the nurses at the ICU

Secondary

MeasureTime frameDescription
Post Traumatic Stress Disorder2 and 6 month after ICU-dischargeMinimum 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 life2 and 6 month after ICU-dischargeMinimum 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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026