Cognitive Dysfunction Following Cardiac Surgery

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative cognitive dysfunction (POCD) is the most common complication after cardiac surgery. This prospective study was conducted to investigate the mechanisms of development of POCD following cardiac surgery taking into account surgical technique (with use or no use of extracorporeal circulation). The investigators focused on the role of inflammatory and stress response to surgical procedure as potential factors involved in the pathogenesis of cognitive dysfunction. Systematic inflammatory response in patients undergoing on-pump or off-pump surgery was analyzed by measuring serum levels of C reactive protein (CRP) and occurrence of systemic inflammatory response syndrome (SIRS). Stress response to surgery was evaluated following cortisol levels and its daily variations. The degree of cognitive dysfunction was assessed based on serum levels of S100β. The effect of dexamethasone on the levels of stress and inflammatory response biomarkers, serum levels of S100β, as well as on the development of POCD was compared with control group that received normal saline.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Hospital Center, Split
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Participants undergoing cardiac surgery: coronary artery bypass grafting, heart valve surgery or a combined procedure,

• Procedure must be elective

Exclusion Criteria:

• Symptomatic cerebrovascular disease,

• Cerebrovascular incident in last 3 years,

• Neurodegenerative disease,

• Psychiatric disease,

• Visual, hearing or motor impairment interfering with cognitive testing,

• Carotid artery stenosis ( ≥50%),

• Myocardial infarction within last 3 months,

• Left ventricular ejection fraction of ≤35%,

• Previous cardiac or carotid surgery,

• Uncontrolled systemic hypertension (blood pressure≥180/110 mmHg),

• Corticosteroid-dependent asthma,

• Chronic obstructive pulmonary disease (COPD),

• Malignancy, liver disease (aspartate transaminase (AST), alanine transaminase (ALT) or bilirubin ˃1.5x above reference range),

• Kidney disease (serum creatinine ˃1.7 mg/dl or blood urea nitrogen ˃50 mg/dL),

• Uncontrolled diabetes mellitus (postprandial glucose ˃200 mg/dL or hemoglobin A1c ˃9%),

• Endocrine and metabolic diseases, requiring steroid treatment longer than 7 days in the past year,

• Alcohol or controlled substance abuse,

• Individuals without primary school education,

• Preoperative C reactive protein ˃0.5 mg/dL,

• Preoperative white blood cell count <3 x109/L or ˃11 x109/L,

• Preoperative Mini mental score <26 points,

• Preoperative Beck's depression inventory score ˃ 19 points,

• Intraoperative plan change (conversion from "off-pump" to "on-pump" and vice versa),

• Need for deep hypothermic circulatory arrest,

• Additional corticosteroid treatment throughout the study period.