The Analysis of Gene Variants Related to POCD in Elderly Patients

NCT05419596 | Unknown

• 1 other identifier: 2022/711
• Study Type: observational
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

The pathophysiology of postoperative cognitive dysfunction (POCD) following surgery may be related to Alzheimer's disease. Different studies show that; low levels of glial cell line-derived growth factor are found in both POCD and Alzheimer, and brain cholinergic markers like Choline acetyl transferase activity, High affinity choline uptake activity, and Acetil Choline (Ach) activity are decreased in Alzheimer disease.We know cholinergic inputs in the basal forebrain have a critical role in many other functions including memory, attention, arousal and sensory processing. Cholinergic neuron located basal section of forebrain degenerate extensively in Alzheimer disease which shares similarities with postoperative delirium and POCD. Ach binds to two well-known receptors in brain that are Nicotinic receptors which implicate several important functions such as "memory, learning, arousal and reward" and Muscarinic receptors which are widely distributed in forebrain and play an important role of development delirium and POCD. Dysfunction of cholinergic system may be one key aspect of postoperative DELIRIUM, POCD and ALZHEIMER disease. In this investigation; we would like to evaluate the relationship between genes encoding inflammation-related mediators detected in postoperative cognitive dysfunction and gene variants in Alzheimer's disease in a larger panel for elder patients undergoing major urologic surgery. Therefore our study will focus on demographic information of the patients (age, gender, comorbidity), neurocognitive tests (1 week before the surgery, postoperative 1st week and postoperative 3rd month), intraoperative data (mean arterial pressure, heart rate, need for inotrope, duration of mechanical ventilation, need for transfusion), and biochemical tests (Preoperative and postoperative blood samples for each patient) which are APOE, phosphatidylinositol-binding clathrin assembly protein, CR1 - complement receptor 1, ATP-binding cassette transporter, IL6, TREM.

Conditions

Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in Interleukin-6 levels in elder atients undergoing major urologic surgery

  Major urologic surgery patients will be evaluated for their different genomic protein levels that are possibly related to cognitive disorders. These proteins consist of APOE, phosphatidylinositol-binding clathrin assembly protein, CR1 (complement receptor 1) , ATP-binding cassette transporter, Interleukin- 6, Triggering receptor expressed on myeloid cells2 (TREM2). Accordingly two blood samples will be gathered from each patient in the preoperative and postoperative period.

  From preoperative 1 hour to postoperative 2 hours

Secondary Outcomes (8)

• Addenbrooke cognitive examinations change (Preoperative to postoperative)

  Up to Postoperative 7 days.

• Addenbrooke cognitive examinations change for the chronic period

  Up to postoperative three months

• The difference in IL-6 between the groups

  Up to postoperative 1 hour

• DNA sequence analysis of APOE gene

  Up to postoperative 1 hour

• DNA sequence analaysis of phospatydil-inositol binding clathrin gene

  Up to postoperative 1 hour

Study Arms (1)

Major Urologic Surgery Group

Elder patients who undergo major urologic surgery will be investigated for the change in genomic protein that are related to cognition. These proteins are APOE, phosphatidyl-inositol-binding clathrin assembly protein, CR1 (complement receptor 1) , ATP-binding cassette transporter, IL6, Triggering receptor expressed on myeloid cells2 (TREM2)

Procedure: Urologic Surgery

Interventions

Urologic Surgery PROCEDURE

Patients undergoing major urologic surgery will be examined with blood samples that will be taken preoperatively and postoperatively. Accordingly several gene variants and proteins will be examined for patients with or without postoperative cognitive dysfunction. These proteins consist of APOE, phosphatidyl-inositol-binding clathrin assembly protein, CR1 - complement receptor 1 , ATP-binding cassette transporter, IL6, Triggering receptor expressed on myeloid cells2 (TREM2).

Major Urologic Surgery Group

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are over 60 years old and scheduled for elective/semielective major urologic surgery

You may qualify if:

• Patients over age of 60 years
• Patients scheduled for major urologic surgery

You may not qualify if:

• Failure of the patient or the person with legal authority to make a decision about him/her.
• Patients with severe hearing-vision problems before surgery.
• Patients with severe neurological-psychiatric disorders before surgery.
• Patients who cannot find a common language.
• Emergency surgeries

Sponsors & Collaborators

• Istanbul University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be evaluated using DNA sequence analysis, Realtime PCR, and ELISA techniques. Proteins including APOE, phosphatidyl inositol-binding clathrin assembly protein, CR1 - complement receptor 1, ATP-binding cassette transporter, IL6,Triggering receptor expressed on myeloid cells2 (TREM2) will be investigated.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Urologic Surgical Procedures

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Meltem Savran Karadeniz, Assoc. Prof.

CONTACT

00904142000; savran@istanbul.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 25, 2023
• Last Updated: June 15, 2022

Record last verified: 2022-06