DANish DELIrium Study On Neurointensive Care Patients (DANDELION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02594982|
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : October 4, 2017
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).
- 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.
- 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|
|Acquired Brain Injuries Delirium Acute Brain Injury||Other: intervention bundle (sedation, pain, mobilization and sleep)|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DANish DELIrium Study On Neurointensive Care Patients. A Two Phase Intervention Study|
|Study Start Date :||August 2015|
|Primary Completion Date :||July 2016|
|Study Completion Date :||July 2016|
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
- 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.
- 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.
- 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.
- 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)
- Quality of life after 12 month after discharge [ Time Frame: 12 month ]12 month after discharge patients are assess with EQ-5D.
- 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)
- cognitive function after 12 month after discharge [ Time Frame: 12 month ]12 month after discharge patients are assess with RBANS.
- 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.
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
|Copenhagen University Hospital, Rigshospitalet|
|Copenhagen, Sealand, Denmark, 2100|
|Principal Investigator:||Kirsten moeller, professor||Rigshospitalet, 2093|