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

This study has been completed.
Sponsor:
Collaborator:
The Novo Nordic Foundation
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01291368
First received: January 20, 2011
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

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


Condition
Delirium
Stress Disorders, Post-Traumatic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care?

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Sedation level and Delirium [ Time Frame: At least twice a day while in the ICU ] [ Designated as safety issue: No ]
    Sedation assessed with RASS and delirium assessed with the CAM-ICU by the nurses at the ICU


Secondary Outcome Measures:
  • Post Traumatic Stress Disorder [ Time Frame: 2 and 6 month after ICU-discharge ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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)


Enrollment: 248
Study Start Date: September 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All adult patients at the ICUs ITA and 600 at Århus Sygehus, Denmark from September 2009 and at Hillerød Intensive, Denmark from 15th October 2010 to 1st October 2011.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291368

Locations
Denmark
Aarhus University Hospital, Århus Sygehus
Aarhus, Denmark, 8000
Anæstesiologisk Afdeling, . Hillerød Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
University of Aarhus
The Novo Nordic Foundation
Investigators
Study Chair: Else Tønnesen, MD Professor Dept. of Anasthesia, Aarhus Universtyhospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01291368     History of Changes
Other Study ID Numbers: 1-16-02-50-09
Study First Received: January 20, 2011
Last Updated: October 19, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: National Board of Health

Keywords provided by University of Aarhus:
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

Additional relevant MeSH terms:
Delirium
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anxiety Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 28, 2014