An observational study in Postoperative Delirium, sponsored by Zhongnan Hospital. Status unknown at 1 site in China. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Zhongnan Hospital · Observational
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), Alzheimer's disease-related factors (Tau, Aβ40/42), 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.
Method:
Inclusion criteria: Eligible patients were at least 65 years old and were scheduled to have hip/knee replacement.
Exclusion Criteria:
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 418 observational studies indexed under Delirium.
Browse Delirium studies →Zhongnan Hospital is the lead sponsor of 103 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients were at least 65 years old and were scheduled to have hip/knee replacement.
Inclusion Criteria: Eligible patients were at least 65 years old and were scheduled to have hip/knee replacement.
Exclusion Criteria:
Group of patients with postoperative delirium
Procedure: hip/knee replacement
Group of patients without postoperative delirium
Procedure: hip/knee replacement
hip/knee replacement
cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine of the participants were measured by DNA sequencing or RNA sequencing before surgery.
Time frame: just before surgery
genome-specific difference between POD and non-POD patients
Compare the exon sequence in blood samples of the participants, as assessed by whole exome sequencing.
Time frame: just before surgery
candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Candidate cell-free DNA, cell-free RNA and exosomal RNA identified in the first outcome were quantified by PCR or RT-PCR on post operative day 1.
Time frame: post operative day 1
candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Candidate cell-free DNA, cell-free RNA and exosomal RNA were quantified by PCR or RT-PCR on post operative day 3.
Time frame: post operative day 3
candidate cell-free DNA, cell-free RNA and exosomal RNA level in blood and urine
Candidate cell-free DNA, cell-free RNA and exosomal RNA were quantified by PCR or RT-PCR on post operative day 7 or the day after delirium disappeared.
Time frame: post operative day 7 or the day after delirium disappeared
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
positive or negative
Time frame: before surgery (from 1 week before to the day before)
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
positive or negative
Time frame: post operative day 1
Delirium severity assessment - Delirium Severity based on 3D-CAM (3D-CAM-S)
ranging from 0 to 7 points
Time frame: post operative day 1
Delirium subtype assessment - Richmond Agitation-Sedation Scale (RASS)
ranging from -5 to +4 points
Time frame: post operative day 1
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
positive or negative
Time frame: post operative day 3
Delirium severity assessment - Delirium Severity based on 3D-CAM (3D-CAM-S)
ranging from 0 to 7 points
Time frame: post operative day 3
Delirium subtype assessment - Richmond Agitation-Sedation Scale (RASS)
ranging from -5 to +4 points
Time frame: post operative day 3
Delirium assessment - 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
positive or negative
Time frame: post operative day 7 or the day after delirium disappeared
Delirium severity assessment - Delirium Severity based on 3D-CAM (3D-CAM-S)
ranging from 0 to 7 points
Time frame: post operative day 7 or the day after delirium disappeared
Delirium subtype assessment - Richmond Agitation-Sedation Scale (RASS)
ranging from -5 to +4 points
Time frame: post operative day 7 or the day after delirium disappeared
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Zhongnan Hospital