Novel BIochemical Markers for Predicting Type 2 NEurological Complications of Surgical Coronary Revascularization (BINER)

Completed

• Conditions: Neurological Complication of Procedure (Disorder)
• Interventions: Other: exposure to type 2 neurological complications

• Registration Number: NCT03493256
• Lead Sponsor: Collegium Medicum w Bydgoszczy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-26
• Study Start: 2018-04-01
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-10
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
type 2 neurological complications present	exposure to type 2 neurological complications	The group of patients diagnosed with postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.

Primary Outcome Measures

Name	Time	Method
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 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 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 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).

Trial Locations

Locations (1)

Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital; 🇵🇱 Bydgoszcz, Kujawsko-Pomorskie, Poland