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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291368
• Other study ID #: 1-16-02-50-09
• Status: Completed
• Phase: N/A
• First received: January 20, 2011
• Last updated: October 19, 2012
• Start date: September 2009
• Est. completion date: February 2012

Study information

• Verified date: October 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: National Board of Health
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Århus Sygehus	Aarhus
Denmark	Anæstesiologisk Afdeling, . Hillerød Hospital	Hillerød

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Novo Nordic Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation level and Delirium	Sedation assessed with RASS and delirium assessed with the CAM-ICU by the nurses at the ICU	At least twice a day while in the ICU	No
Secondary	Post Traumatic Stress Disorder	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)	2 and 6 month after ICU-discharge	No
Secondary	Health-related quality of life	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)	2 and 6 month after ICU-discharge	No