An observational study in Neurological Complication of Procedure (Disorder), sponsored by Collegium Medicum w Bydgoszczy. Completed at 1 site in Poland. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Collegium Medicum w Bydgoszczy · Observational
In this single center prospective cohort study a total of 100 patients scheduled for elective off-pump CABG will be recruited. They will be allocated to one study and one control group according to the presence or absence of postoperative type 2 neurological complications. The two groups will be compared in terms of serum concentrations of glial fibrillary acidic protein (GFAP), neuroserpin (NSP), phosphorylated axonal neurofilament subunit H (pNfH) and visinin-like protein 1 (VILIP-1) at the time of skin incision and closure as well as 24 hours and 7 days following surgery. Diagnostic performance of these markers for predicting type 2 neurological complications of off-pump CABG will be assessed.
All participants will be recruited from patients scheduled for elective off-pump CABG at the Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital, Bydgoszcz, Poland.
Exclusion Criteria:
The group of patients diagnosed with postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.
Other: exposure to type 2 neurological complications
The group of patients without neurological complications.
exposure to postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.
Assessment of serum GFAP concentration (ng/ml) changes.
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of glial fibrillary acidic protein (GFAP).
Time frame: GFAP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Assessment of serum NSP concentration (ng/ml) changes.
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin (NSP).
Time frame: NSP concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Assessment of serum pNfH concentration (ng/ml) changes.
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin phosphorylated axonal neurofilament subunit H (pNfH).
Time frame: pNfH concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Assessment of serum VILIP-1 concentration (ng/ml) changes.
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of visinin-like protein 1 (VILIP-1).
Time frame: VILIP-1 concentrations will be measured preoperatively (at the time of initial skin incision), at the completion of surgery (at the time of skin closure) as well as 24 hours and 7 days following off-pump Coronary Artery Bypass Grafting (CABG).
Plan to share: Yes — The data that support the findings of this study are available from the corresponding author upon reasonable request.
Supporting information: Study protocol, Csr
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Collegium Medicum w Bydgoszczy