Completed

NCT Number: NCT01291368

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

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

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Key information

Conditions

Delirium Anxiety Disorders Behavior Behavioral Symptoms Confusion Depression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Århus Sygehus, Aarhus, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Sedation level and Delirium

Time frame: 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 outcomes

Post Traumatic Stress Disorder

Time frame: 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)
Health-related quality of life

Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

The Novo Nordic Foundation

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Feb 8, 2011
Registry last updated: Oct 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed