Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923243
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2021-04-20
Brief Title:
The Neuro-epigenetics Biomarkers of Postoperative Delirium in Elderly Patients Undergoing HipKnee Replacement
Sponsor:
Zhongnan Hospital
Organization:
Zhongnan Hospital
Study Overview
Official Title:
The Neuro-epigenetics Biomarkers of Postoperative Delirium in Elderly Patients Undergoing HipKnee Replacement
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Postoperative delirium POD an acute transient fluctuating disturbance in attention cognition and level of consciousness is a common 15-53 postoperative complication and it is associated with longer hospital stays worse functional outcomes higher healthcare costs and increased mortality However at the current time effective prevention and treatment are not only hampered by lack of knowledge about the neuropathogenesis of POD but also by a lack of biomarkers that could predict individual risk and assess diagnosis and severity of POD
Recent studies have focused on inflammatory markers IL-1 IL-6 IL-8 IL-10 CRP Alzheimers disease-related factors Tau Aβ4042 and nerve injury factors S100β NSE but failed to establishing causality between these markers and POD Furthermore these results were contradictory Previous study of the investigators found that the dysregulation of preoperative microRNA miR-146a and miR-181c in cerebrospinal fluid CSF and serum was associated with the development and severity of POD Therefore the investigators hypothesized these neurimmiRs and other neuro-epigenetics biomarkers might participate in the neuropathogenesis of POD
Purpose Aims to search for neuro-epigenetics biomarkers to predict and diagnose POD
Recent studies have focused on inflammatory markers IL-1 IL-6 IL-8 IL-10 CRP Alzheimers disease-related factors Tau Aβ4042 and nerve injury factors S100β NSE but failed to establishing causality between these markers and POD Furthermore these results were contradictory Previous study of the investigators found that the dysregulation of preoperative microRNA miR-146a and miR-181c in cerebrospinal fluid CSF and serum was associated with the development and severity of POD Therefore the investigators hypothesized these neurimmiRs and other neuro-epigenetics biomarkers might participate in the neuropathogenesis of POD
Purpose Aims to search for neuro-epigenetics biomarkers to predict and diagnose POD
Detailed Description:
Method
1 Study design This study is a prospective investigation that searches for neuro-epigenetics biomarkers to predict and diagnose POD
2 Inclusion criteria Exclusion Criteria
Inclusion criteria Eligible patients were at least 65 years old and were scheduled to have hipknee replacement
Exclusion Criteria
1 a past medical history of neurological or clinically evident neurovascular disease eg Alzheimers disease other forms of dementia stroke
2 Patients diagnosed with malignant or benign tumors
3 Mini-Mental State Examination MMSE scores of 26 or less
4 American Society of Anesthesiologists ASA score a global score that assesses the physical status of patients before surgery ranging from 1 normal health to 5 moribund greater than 3
5 a history of alcohol abuse and drug dependence
6 inability to read or severe visual or auditory deficits
7 unwillingness to comply with the protocol or procedures
1 Study design This study is a prospective investigation that searches for neuro-epigenetics biomarkers to predict and diagnose POD
2 Inclusion criteria Exclusion Criteria
Inclusion criteria Eligible patients were at least 65 years old and were scheduled to have hipknee replacement
Exclusion Criteria
1 a past medical history of neurological or clinically evident neurovascular disease eg Alzheimers disease other forms of dementia stroke
2 Patients diagnosed with malignant or benign tumors
3 Mini-Mental State Examination MMSE scores of 26 or less
4 American Society of Anesthesiologists ASA score a global score that assesses the physical status of patients before surgery ranging from 1 normal health to 5 moribund greater than 3
5 a history of alcohol abuse and drug dependence
6 inability to read or severe visual or auditory deficits
7 unwillingness to comply with the protocol or procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None