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

Completed

• Conditions: Delirium; Stress Disorders, Post-Traumatic

• Registration Number: NCT01291368
• Lead Sponsor: University of Aarhus

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

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-19
• Last Update Posted: 2012-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sedation level and Delirium	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

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	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)
Post Traumatic Stress Disorder	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)

Trial Locations

Locations (2)

Anæstesiologisk Afdeling, . Hillerød Hospital; 🇩🇰 Hillerød, Denmark

Aarhus University Hospital, Århus Sygehus; 🇩🇰 Aarhus, Denmark