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

C

Collegium Medicum w Bydgoszczy

Status

Completed

Conditions

Neurological Complication of Procedure (Disorder)

Treatments

Other: exposure to type 2 neurological complications

Study type

Observational

Funder types

Other

Identifiers

NCT03493256
KB 776/2017

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial design

100 participants in 2 patient groups

type 2 neurological complications present
Description:
The group of patients diagnosed with postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.
Treatment:
Other: exposure to type 2 neurological complications
type 2 neurological complications absent
Description:
The group of patients without neurological complications.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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