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

Sponsor
Moscow Clinical Scientific Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03683537
Collaborator
(none)
20
Enrollment
1
Location
19
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Glial fibrillary acidic protein

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Association Between Changes of GFAP After Surgery and Postoperative Delayed Cognitive Recovery
Actual Study Start Date :
Feb 15, 2018
Anticipated Primary Completion Date :
Jul 15, 2019
Anticipated Study Completion Date :
Sep 15, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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.
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
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.

Outcome Measures

Primary Outcome Measures

  1. Changes in serum GFAP [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • ASA IV-V

  • Severe neurodegenerative or psychological diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 Moscow Clinical Scientific Center Moscow Russian Federation 111123

Sponsors and Collaborators

  • Moscow Clinical Scientific Center

Investigators

  • Study Chair: Valery Subbotin, Ph.D., M.D., Moscow Clinical Scintific Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Moscow Clinical Scientific Center
ClinicalTrials.gov Identifier:
NCT03683537
Other Study ID Numbers:
  • MKNC 02/2018
First Posted:
Sep 25, 2018
Last Update Posted:
Jun 24, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Delirium
Postoperative Cognitive Complications
Gliosis
Cognitive Dysfunction

Study Results

No Results Posted as of Jun 24, 2019