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DANish DELIrium Study On Neurointensive Care Patients (DANDELION)

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ClinicalTrials.gov Identifier: NCT02594982
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Kirsten Moller, Rigshospitalet, Denmark

Brief Summary:

Abstract Background Studies have shown that delirium in medical and surgical intensive care units (ICUs) increases mortality, length of stay (LOS) as well as the risk of dementia symptoms and cerebral atrophy after discharge. Only few studies have investigated delirium in the neurointensive care unit (N-ICU). Delirium is most often assessed by one of two instruments: Intensive Care Delirium Screening Checklist (ICDSC) or the Confusion Assessment Method for the ICU (CAM-ICU).

Aims

  1. To measure the effect of a systematic intervention (sedation, sleep, mobilization and pain) on delirium symptoms in patients with acute acquired brain injury in N-ICU.
  2. To validate the ICDSC and CAM-ICU to patients with acute acquired brain injury Method The design of the study is a two-phase interventional trial. Based on a power calculation, 56 patients will be enrolled both in the baseline and the intervention group (n=112).

Part 1: A baseline investigation will be conducted to establish prevalence, duration and type of delirium symptoms in patients with acute acquired brain injury before implementing the intervention bundle.

Part 2: A systematic Intervention protocol will be implemented in the N-ICU. The Intervention elements consist of a sedation, sleep, mobilization and pain treatment regimen based on the newest available evidence.

Enrolled patients will be contacted 12 months after discharge for a follow-up including a quality of life with (EuroQoL-5D) questionnaire, a cognitive test measuring their cognitive end point (Repeatable Battery for Assessment of the Neuropsychological Status) and a short test for dementia symptoms (MMSE, Mini Mental State Examination).


Condition or disease Intervention/treatment Phase
Acquired Brain Injuries Delirium Acute Brain Injury Other: intervention bundle (sedation, pain, mobilization and sleep) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: DANish DELIrium Study On Neurointensive Care Patients. A Two Phase Intervention Study
Study Start Date : August 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
intervention bundle
An intervention bundle consisting of optimized sedation, pain assessment and treatment, early mobilization and sleep.
Other: intervention bundle (sedation, pain, mobilization and sleep)

Sedation: Sedation after target RASS Pain: Implementing a pain guideline and CPOT for pain assessment. Mobilization: Implementing a guideline on early mobilization and a daily prescribed mobilization level.

Sleep: Implementing a daily quite time and changing procedures to minimize noise during the night





Primary Outcome Measures :
  1. Duration of delirium symptoms. [ Time Frame: Minimum 48 hours and up to 4 weeks ]
    Patients are assessed two times per day for delirium symptoms with ICDSC and the CAM-ICU during their stay on the N-ICU. duration of delirium symptoms measured by CAM-ICU and ICDSC will be analysed individually and the one with the best performance test will be presented as the primary outcome measure.


Secondary Outcome Measures :
  1. Validation of ICDSC and CAM-ICU [ Time Frame: 2 days. On the first and second assessable day (RASS -2 or above). ]
    Investigate sensitivity and specificity of ICDSC and CAM-ICU. A psychiatric team assess patients with diagnostic criteria DSM-V and ICD-10. Laura Krone Larsen and nurses assess patient with the ICDSC and the CAM-ICU for comparison with the psychiatric assessment.

  2. Prevalence of delirium symptoms [ Time Frame: 1 day and up to 4 weeks. ]
    During baseline (phase 1) and the intervention phase (phase 2) patients are assessed twice daily for delirium symptoms with the ICDSC and CAM-ICU.

  3. Length of Stay [ Time Frame: 2 days (48 hours) and up til 4 weeks ]
    LOS is compared between the baseline (phase 1) and the intervention phase (phase 2)

  4. Quality of life after 12 month after discharge [ Time Frame: 12 month ]
    12 month after discharge patients are assess with EQ-5D.

  5. Mortality [ Time Frame: 1 year ]
    Mortality up til one year after discharge is compared between the baseline (phase 1) and the intervention phase (phase 2)

  6. cognitive function after 12 month after discharge [ Time Frame: 12 month ]
    12 month after discharge patients are assess with RBANS.

  7. Type of delirium symptoms [ Time Frame: 1 day (24 hours) and up to 4 weeks. ]
    Hyper, hypo or mixed delirium symptoms assessed with RASS and in words by Laura Krone Larsen and Nurses. Comments and descriptions on delirium symptoms are collected during phase 1 and phase 2.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Danish speaking adults (18 years or above)
  • Expected N-ICU length of stay (LOS) more than 48 hours
  • Admitted with acute brain injury from subarachnoid hemorrhage (SAH), intracranial hemorrhage (ICH) or traumatic brain injury (TBI).

Exclusion Criteria:

  • Patients not expected to survive 48 hours
  • Richmond Agitation-Sedation Score (RASS) of -4 or -5 during the stay in the N-ICU.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594982


Locations
Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Sealand, Denmark, 2100
Sponsors and Collaborators
Kirsten Moller
Investigators
Principal Investigator: Kirsten moeller, professor Rigshospitalet, 2093

Publications:

Responsible Party: Kirsten Moller, Professor, dept. of Neuroanaesthesiology, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02594982     History of Changes
Other Study ID Numbers: H-15007689
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2016

Keywords provided by Kirsten Moller, Rigshospitalet, Denmark:
Delirium
intensive care nursing
Acute acquired brain injury
neurointensive care
Intensive care delirium screening checklist
Confusion Assessment Method for the ICU

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Wounds and Injuries
Delirium
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders