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 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 |
| 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
|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Lina Yu, MD | +86 13958033387 | zryulina@zju.edu.cn |
| 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 |
|
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| 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. |
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| 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
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
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:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| 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 |
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| IPD Sharing Statement |
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| 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 | ||||