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出境医 / 临床实验 / Correlation Between Plasma Oxidized Low Density Lipoprotein Levels And Postoperative Delirium

Correlation Between Plasma Oxidized Low Density Lipoprotein Levels And Postoperative Delirium

Study Description
Brief Summary:

Postoperative delirium (POD) refers to an acute neurocognitive disorder that occurs within 1 week after surgery or before discharge. Old age is one of the important risk factors for postoperative delirium. The incidence rate of the elderly is high, and the life span of human beings is increasing. Postoperative delirium has adverse effects on both short-term and long-term outcomes, including mortality, ability to work, and dependence on society.

Low-density lipoprotein (LDL) is a key molecule in the cholesterol transport mechanism and is easily oxidized to oxidized low-density lipoprotein (OxLDL). Oxidized low density lipoproteins are immunogenic and are also cytotoxic to endothelial cells. Some studies have shown that increased oxidative stress is one of the earliest changes in disease, and similar signs can be detected in patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI), such as protein oxidation and lipids. An increase in the quality of the peroxidation index. For the study of anesthesiology, oxidative stress theory has long been recognized as one of the mechanisms of postoperative delirium. We have a hypothesis that plasma oxidized low-density lipoprotein levels are associated with postoperative delirium and can be used as an early warning marker for disease occurrence.

Based on clinical research data, we conducted a prospective cohort study to explore the correlation between plasma oxidized low-density lipoprotein levels and postoperative sputum, providing clinical prediction and diagnostic value.


Condition or disease Intervention/treatment
Postoperative Delirium Other: plasma oxidized low-density lipoprotein levels

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Correlation Between Plasma Oxidized Low Density Lipoprotein Levels And Postoperative Delirium
Estimated Study Start Date : May 20, 2019
Estimated Primary Completion Date : September 20, 2019
Estimated Study Completion Date : September 20, 2019
Arms and Interventions
Group/Cohort Intervention/treatment
Case group
Patients with postoperative delirium.
Other: plasma oxidized low-density lipoprotein levels
Detection of plasma oxidized low-density lipoprotein levels

Control group
Patients who have not had postoperative delirium.
Other: plasma oxidized low-density lipoprotein levels
Detection of plasma oxidized low-density lipoprotein levels

Outcome Measures
Primary Outcome Measures :
  1. plasma oxidized low-density lipoprotein levels [ Time Frame: through study completion, an average of 4 months ]
    Preoperative plasma oxidized low-density lipoprotein levels

  2. plasma oxidized low-density lipoprotein levels [ Time Frame: through study completion, an average of 4 months ]
    Postoperative plasma oxidized low-density lipoprotein levels


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in orthopedics, urology and general surgery .
Criteria

Inclusion Criteria:

  • Surgical treatment was performed in our hospital under standard anesthesia.
  • Patients in orthopedics, urology and general surgery.

Exclusion Criteria:

  • Patients with mental illness or taking psychotropic substances before surgery.
  • Preoperative dementia or cognitive dysfunction.
  • Unable to communicate and cooperate with patients due to coma, language barrier or end-stage disease before surgery.
  • ASA greater or equal to 4.
  • Patients who have undergone neurosurgery and cardiac vascular surgery.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lina Yu, MD +86 13958033387 zryulina@zju.edu.cn

Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Tracking Information
First Submitted Date May 19, 2019
First Posted Date May 30, 2019
Last Update Posted Date May 30, 2019
Estimated Study Start Date May 20, 2019
Estimated Primary Completion Date September 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2019)
  • plasma oxidized low-density lipoprotein levels [ Time Frame: through study completion, an average of 4 months ]
    Preoperative plasma oxidized low-density lipoprotein levels
  • plasma oxidized low-density lipoprotein levels [ Time Frame: through study completion, an average of 4 months ]
    Postoperative plasma oxidized low-density lipoprotein levels
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlation Between Plasma Oxidized Low Density Lipoprotein Levels And Postoperative Delirium
Official Title Correlation Between Plasma Oxidized Low Density Lipoprotein Levels And Postoperative Delirium
Brief Summary

Postoperative delirium (POD) refers to an acute neurocognitive disorder that occurs within 1 week after surgery or before discharge. Old age is one of the important risk factors for postoperative delirium. The incidence rate of the elderly is high, and the life span of human beings is increasing. Postoperative delirium has adverse effects on both short-term and long-term outcomes, including mortality, ability to work, and dependence on society.

Low-density lipoprotein (LDL) is a key molecule in the cholesterol transport mechanism and is easily oxidized to oxidized low-density lipoprotein (OxLDL). Oxidized low density lipoproteins are immunogenic and are also cytotoxic to endothelial cells. Some studies have shown that increased oxidative stress is one of the earliest changes in disease, and similar signs can be detected in patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI), such as protein oxidation and lipids. An increase in the quality of the peroxidation index. For the study of anesthesiology, oxidative stress theory has long been recognized as one of the mechanisms of postoperative delirium. We have a hypothesis that plasma oxidized low-density lipoprotein levels are associated with postoperative delirium and can be used as an early warning marker for disease occurrence.

Based on clinical research data, we conducted a prospective cohort study to explore the correlation between plasma oxidized low-density lipoprotein levels and postoperative sputum, providing clinical prediction and diagnostic value.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 7 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients in orthopedics, urology and general surgery .
Condition Postoperative Delirium
Intervention Other: plasma oxidized low-density lipoprotein levels
Detection of plasma oxidized low-density lipoprotein levels
Study Groups/Cohorts
  • Case group
    Patients with postoperative delirium.
    Intervention: Other: plasma oxidized low-density lipoprotein levels
  • Control group
    Patients who have not had postoperative delirium.
    Intervention: Other: plasma oxidized low-density lipoprotein levels
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 28, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 20, 2019
Estimated Primary Completion Date September 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Surgical treatment was performed in our hospital under standard anesthesia.
  • Patients in orthopedics, urology and general surgery.

Exclusion Criteria:

  • Patients with mental illness or taking psychotropic substances before surgery.
  • Preoperative dementia or cognitive dysfunction.
  • Unable to communicate and cooperate with patients due to coma, language barrier or end-stage disease before surgery.
  • ASA greater or equal to 4.
  • Patients who have undergone neurosurgery and cardiac vascular surgery.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03968887
Other Study ID Numbers 2019-092
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators Not Provided
Investigators Not Provided
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date May 2019