NCT03968887

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

May 19, 2019

Last Update Submit

May 28, 2019

Conditions

Keywords

Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

  • plasma oxidized low-density lipoprotein levels

    Preoperative plasma oxidized low-density lipoprotein levels

    through study completion, an average of 4 months

  • plasma oxidized low-density lipoprotein levels

    Postoperative plasma oxidized low-density lipoprotein levels

    through study completion, an average of 4 months

Study Arms (2)

Case group

Patients with postoperative delirium.

Other: plasma oxidized low-density lipoprotein levels

Control group

Patients who have not had postoperative delirium.

Other: plasma oxidized low-density lipoprotein levels

Interventions

Detection of plasma oxidized low-density lipoprotein levels

Case groupControl group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in orthopedics, urology and general surgery .

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2019

First Posted

May 30, 2019

Study Start

May 20, 2019

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share