drugset / Trial / NCT02767713

Cognitive Dysfunction Following Cardiac Surgery

NCT02767713 ↗

Phase 4 Unknown 171 enrolled Clinical Hospital Center, Split
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2015-03
Primary completion
2016-01
Completion
2016-12

Outcome

Met primary endpoint

paper the dexamethasone group showed statistically significant reductions in the incidence of POCD (relative risk, 0.43; 95% confidence interval, 0.21 to 0.89; P = 0.02) PMID 28985195 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.1 mg/kg Intravenous