Clinical trial NCT05105451: Study on the Characteristics of Non-targeted Metabolomics and EEG of Delayed Neurocognitive Recovery in Elderly Patients
Official title: Study on the Characteristics of Non-targeted Metabolomics and EEG of Delayed Neurocognitive Recovery in Elderly Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Delayed Neurocognitive Recovery
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our research is a single center, nested case-control study. Preoperatively collect the information of the elderly patients over 65 years old without undergoing craniocerebral operations, including the vital signs, the examination reports and other related data after excluding the factors that can't be included in the group. The patients' health scales and dNCR. scales were evaluated.

Brief summary: Perioperative neurocognitive disorder (PND) refers to a broad range of postoperative cognitive complications, including preoperatively diagnosed cognitive decline, postoperative delirium (POD), delayed neurocognitive recovery (dNCR), and neurocognitive disorders . Among them, dNCR refers to a decline in cognitive function that occurs approximately 1-4 weeks after anesthesia/surgery in elderly patients. It is associated with an increased risk of postoperative complications and an increased length of hospital stay.

The identification of potential predictive biomarkers would be beneficial for determining the individual risk of developing dNCR and for postoperative management of elderly patients. Although some predictive markers for PNDs, such as inflammatory factors, tau protein, S100B protein, neuron-specific enolase, and brain-derived neurotrophic factor, are widely known, most of them are postoperative predictive markers. The markers that can be used to predict PNDs before anesthesia/surgery are still largely unknown.

Preoperative markers allow us to identify individuals who are susceptible to dNCR and intervene early. It is unclear whether the metabolic status of preoperative patients is related to the occurrence of postoperative cognitive dysfunction (POCD). In the framework of systems biology based on genome, transcriptome, proteome, and metabolome, metabolomics is the closest to biological phenotypes because it reflects biological events that have occurred in living organisms. Considering that metabolome reflects the metabolites of all biochemical reactions that have already taken place in an organism and contains a huge amount of information about an organism's health, preoperative patient metabolites may be a useful predictive biomarker. In this study, we used serum metabolomics to develop non-invasive, easily detectable, and inexpensive preoperative biomarkers from patient blood to determine the individual risk of dNCR and the relationship between metabolic system abnormalities and the pathogenesis of dNCR.


Eligibility criteria: Inclusion Criteria:

* Gender: no gender limit
* 65 years or older .
* Complete the operation in our hospital
* ASA classification I-II level
* Agree to participate in this research and agree to sign an informed consent form

Exclusion Criteria:

* History of preoperative psychosis and psychotropic drug use
* The subject is diagnosed with AD;
* Abnormal preoperative mental scale assessment
* Have a history of emergency rescue during the perioperative period

Primary outcomes:
measure: MMSE (mini-mental state examiniation)
timeFrame: 1 day after surgery
measure: MOCA (Montreal Cognitive Assessment)
timeFrame: 1 day after surgery
measure: MMSE (mini-mental state examiniation)
timeFrame: 3 day after surgery
measure: MOCA (Montreal Cognitive Assessment)
timeFrame: 3 day after surgery
measure: MMSE (mini-mental state examiniation)
timeFrame: 7 day after surgery
measure: MOCA (Montreal Cognitive Assessment)
timeFrame: 7 day after surgery
measure: MOCA (Montreal Cognitive Assessment)
timeFrame: right before surgery
measure: MMSE (mini-mental state examiniation)
timeFrame: right before surgery
measure: T-MoCA (The telephone MoCA)
timeFrame: 15 day after surgery
measure: T-MoCA (The telephone MoCA)
timeFrame: 30 day after surgery
Secondary outcomes:
measure: 3D-CAM
timeFrame: 1 day after surgery
measure: Self-Rating Anxiety Scale
timeFrame: right before surgery
measure: Self-rating depression scale
timeFrame: right before surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 9Th Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Hong Jiang, Doctor
role: STUDY_DIRECTOR
References: