Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| type 2 neurological complications present The group of patients diagnosed with postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently. |
Other: exposure to type 2 neurological complications
exposure to postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.
|
| type 2 neurological complications absent The group of patients without neurological complications. |
Outcome Measures
Primary Outcome Measures
- Assessment of serum GFAP concentration (ng/ml) changes. [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).]
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of glial fibrillary acidic protein (GFAP).
- Assessment of serum NSP concentration (ng/ml) changes. [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).]
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of neuroserpin (NSP).
- Assessment of serum pNfH concentration (ng/ml) changes. [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).]
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).
- Assessment of serum VILIP-1 concentration (ng/ml) changes. [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).]
Comparison of patients with and without type 2 neurological complications in respect to changes from baseline concentration of visinin-like protein 1 (VILIP-1).
Eligibility Criteria
Criteria
Inclusion Criteria:
- patients scheduled for elective off-pump Coronary Artery Bypass Grafting (CABG)
Exclusion Criteria:
-
neurological or psychiatric disorders
-
alcohol or drug abuse
-
preoperative left ventricular ejection fraction of less than 30%
-
extracranial carotid artery stenosis of more than 70%
-
scoring below age- and education-adjusted cut-off values in Mini-Mental State Examination (MMSE)
-
scoring over seven points on the subscales of the Hospital Anxiety and Depression Scale (HADS)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital | Bydgoszcz | Kujawsko-Pomorskie | Poland | 85-094 |
Sponsors and Collaborators
- Collegium Medicum w Bydgoszczy
Investigators
- Principal Investigator: Krzysztof Szwed, Dr, Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KB 776/2017