Sponsor study identifier
observational
152
1 country
1
Study Start
January 7, 2020
Actual (reported)Primary Completion
December 8, 2021
Actual (reported)Study Completion
December 8, 2021
Actual (reported)Delirium is one of the most common complications after cardiac surgeries, incidence of which is 20\~70%. Causes and pathophysiology of delirium has not been elucidated yet, however, inflammatory response of the nervous system, imbalance of neurotransmitters and ischemia-reperfusion injury of brain tissue are thought to play a big role. 'Neurofilament light (Nfl)' and 'Tau' are proteins that comprise neurons, which are released into blood during acute brain injury. Increased serum concentrations of these markers are acknowledged to be associated with worse clinical outcomes in patients with acute brain injury. These proteins are also closely linked to degenerative changes in the nervous system and cognitive decline in Alzheimer's disease. Therefore, the increase in blood levels of 'Nfl' and 'Tau' may be related to the development of delirium. The aim of this study is to investigate the association between 'Nfl' and 'Tau', serum markers of damage of the nervous system, and the development of delirium after cardiac surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 8, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 9, 2019
Actual (reported)December 11, 2019
Actual (reported)January 7, 2020
Actual (reported)December 8, 2021
Actual (reported)December 8, 2021
Actual (reported)Postoperative delirium
From the postoperative day 0 to 7, CAM-ICU (for mechanically ventilated patients) or 3D-CAM (for extubated patients) is performed twice a day. Electronic medical records of the patients are also assessed.
Postoperative 7 days
Patients older than 65 years and undergoing elective valvular heart surgery
Patients undergoing valvular heart surgery (\>65 years old)
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
Plasma for Nfl/Tau measurement
152 participants (actual enrollment reported by the registry).
First Submitted
December 9, 2019
First Posted
December 11, 2019
Study Start
January 7, 2020
Actual (reported)Relationship Between Perioperative Sleep Disturbance and Postoperative Delirium
Contact the study team to confirm eligibility.
Primary Completion
December 8, 2021
Actual (reported)Study Completion
December 8, 2021
Actual (reported)Last Updated
January 10, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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