Evaluation of High-dose Corticosteroids on Microcirculation Alterations in Cardiac Surgery, by FMD (Flow Mediated vasoDilation), Near Infrared Spectrophotometry (NIRS) and Biological Analysis (Syndecan-1) (SICS)

NCT02798068 Phase 4 TERMINATED

Cardiac surgery is sometimes associated with organ dysfunction of variable severity (renal insufficiency, cognitive decline, arrhythmias, ARDS). The phenomenon responsible is an intense inflammatory reaction induced by cardiopulmonary bypass, leading to microcirculation alterations, specially in endothelial cell and its protective layer - glycocalyx. Endothelial dysfunction then reduces the reactivity of peripheral tissues to hypoxia, and is associated with bad prognosis. High - dose corticoids administration at anesthesia induction in cardiac surgery could attenuate the intensity of this inflammatory reaction, and represents the current practice in our hospital. Nevertheless, this attitude is abandoned in numerous cardiac surgery centres.

Details

Lead sponsor	Erasme University Hospital
Phase	Phase 4
Status	TERMINATED
Enrolment	40
Start date	2016-05
Completion	2021-09

Conditions

• C.Surgical Procedure
• Cardiac

Interventions

• Solu-medrol or placebo administration

Primary outcomes

• Flow Mediated Vasodilation change — 3 measurements of 5 minutes each - vascular occlusion test once daily during 48h.
  Arterial diameter variation and Doppler flow are measured at brachial artery during vascular occlusion test - viariation of diameter and doppler flow befor and after cuff release will be assessed

Countries

Belgium