Study on the Characteristics of Non-targeted Metabolomics... | NCT05105451

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients in the control group were followed up without dNCR postoperatively.		If the MOCA or MMSE assessment all show a negative resluts at all time point.	Other: Collecting clinical data, EGG，arterial blood gas data and venous blood sample
Patients in the case group were followed up with dNCR postoperatively.		If the MOCA assessment is positive at any time point after surgery, and there is a positive MMSE at any time point after surgery(no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.	Other: Collecting clinical data, EGG，arterial blood gas data and venous blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collecting clinical data, EGG，arterial blood gas data and venous blood sample	Other	Collecting clinical data(before induction of anesthesia and first day after surgery), EGG（first day after surgery），arterial blood gas data(before induction of anesthesia and first day after surgery) and venous blood sample （before induction of anesthesia and first day, third day and 7th day after surgery）

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MMSE (mini-mental state examiniation)	MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.	1 day after surgery
MOCA (Montreal Cognitive Assessment)	MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.	1 day after surgery
MMSE (mini-mental state examiniation)	MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.	3 day after surgery
MOCA (Montreal Cognitive Assessment)	MOCA sacle score, If the MOCA assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.	3 day after surgery
MMSE (mini-mental state examiniation)	MMSE scale score, If the MMSE assessment is positive at any time point, and there is a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR. a positive MMSE at any time point (no need for both MOCA and MMSE to be positive at the same time), it is defined as the occurrence of dNCR.

Measure	Description	Time Frame
3D-CAM	3D-CAM score	1 day after surgery
Self-Rating Anxiety Scale	Self-Rating Anxiety Scale score	right before surgery

Eligibility Module

Name	Affiliation	Role
Hong Jiang, Doctor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai 9Th Hospital		Shanghai	Shanghai Municipality	200000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40518008	Derived	Zhang L, Liu J, Zhou R, Liu J, Zhang J, Mao H, Yan J, Jiang H. Preoperative tyrosine is associated with postoperative delayed neurocognitive recovery in elderly: Evidence from two hospitals. Clin Nutr ESPEN. 2025 Aug;68:727-736. doi: 10.1016/j.clnesp.2025.06.016. Epub 2025 Jun 13.
37583434	Derived	Mao H, Huang H, Zhou R, Zhu J, Yan J, Jiang H, Zhang L. High preoperative blood oxaloacetate and 2-aminoadipic acid levels are associated with postoperative delayed neurocognitive recovery. Front Endocrinol (Lausanne). 2023 Jul 31;14:1212815. doi: 10.3389/fendo.2023.1212815. eCollection 2023.