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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01291368
Other study ID # 1-16-02-50-09
Secondary ID
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


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
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