Association Between Changes of GFAP After Surgery and Postoperative Delayed Cognitive Recovery

NCT03683537 | Completed

• 1 other identifier: MKNC 02/2018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of serum level of glial fibrillary acidic protein (GFAP) before surgery (on the day of surgery), 24 hours after surgery and on 3 or 4 postoperative day. Neuropsychological testing before surgery and on 3 or 4 day after surgery. Investigation of relationship between changes of GFAP and scores of neuropsychological tests.

Conditions

Astrogliosis; Postoperative Cognitive Dysfunction; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Changes in serum GFAP

  GFAP(3) - GFAP (1); GFAP (2) - GFAP (1)

  1 year

Study Arms (2)

Delayed Neurocognitive decline

Patients in whom there is Delayed Neurocognitive Recovery (DNR) after surgery, based on neuropsychological tests or clinically. DNR is defined as follow: 1)decrease of scores of neuropsychological test scores for more than 1 standard deviation (SD) of these tests; 2)clinically - inability of patient to perform test after surgery because of neurocognitive impairment.

Diagnostic Test: Glial fibrillary acidic protein

Normal postop neurocognitive function

Patients in whom there is no clinical signs of DNR, defined as in previous group.

Diagnostic Test: Glial fibrillary acidic protein

Interventions

Glial fibrillary acidic protein DIAGNOSTIC_TEST

3 samples of serum are drawn from patients. The 1st Sample of patient serum is drawn before induction into anesthesia. The 2nd is drawn 24 hours after the 1st one. The 3rd sample is drawn on 3 or 4 postoperative day. All samples collected and preserved in the same temperature as required for ELISA.

Delayed Neurocognitive decline; Normal postop neurocognitive function

Eligibility Criteria

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

Study Population

All patients who undergo surgery in Moscow Clinical Scientific Center

You may qualify if:

• Patients with different diseases, who require prolonged laparoscopy or open surgery
• Age more than 60
• ASA I-III
• Informed consent to participate in the study

You may not qualify if:

• ASA IV-V
• Severe neurodegenerative or psychological diseases

Sponsors & Collaborators

• Moscow Clinical Scientific Center: lead

Study Sites (1)

Moscow Clinical Scientific Center

Moscow, Moscow, 111123, Russia

Location

MeSH Terms

Conditions

Gliosis; Postoperative Cognitive Complications; Emergence Delirium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Valery Subbotin, Ph.D., M.D.

  Moscow Clinical Scintific Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 25, 2018
• Study Start: February 15, 2018
• Primary Completion: November 15, 2021
• Study Completion: December 15, 2021
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

RU (1)