Cardiac pathology eligible for surgery
Conditions
Interventions
Trade Name: Solu - Medrol 500 mg
Product Name: Solu - Medrol 500mg
Product Code: H02AB04
Pharmaceutical Form: Injection
INN or Proposed INN: 277 S 102 F12
Other descriptive name: METHYLPREDNISOLONE SO
Sponsors
Hôpital Erasme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: all patients eligible for cardiac surgery with CBP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Age under 18years Allergy to corticoids Extreme emergency surgery Impossibility of pneumatic cuff placement on upper limb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Variation of diameter of brachial artery and peripheral StO2 variation: A/ FMD (Flow Mediated vasoDilation) which is a non invasive technique considered as the gold standard for endothelial reactivity evaluation since the end of 1990s. It is based on echographic measurement of brachial artery diameter variation and the Doppler flow evaluation, during an episode of transient ischemia induced by pneumatic cuff inflation (vascular occlusion test). Some studies showed a reversible alteration of endothelial function mainly after cardiac surgery using CBP with continuous blood flow (FMD variation of about 11%). We are expecting a reduction of endothelial dysfunction with corticoids by 5%, In previous studies, variation is already significative when FMD varies from 1,5 – 2%. B/ NIRS (near infrared spectroscopy) – it’s a non invasive technique which measures peripheral tissue oxygen saturation and allows to assess oxygen consumption and microcirculation reactivity during an arterial occlusion test distally to compressive cuff. Alterations of the variables derived from delta StO2 (peripheral tissue oxygen saturation) after an ischemic – reperfusion event, rather than absolute value of StO2 are predictive of bad prognosis in a septic patient or in severe head injury. These variables are delta StO2, HbT (total tissue hemoglobin) and THI (muscular hemoglobin index). From these elements can be calculated others: RdecStO2 (StO2 decrease rate during ischemic event reflecting the tissue oxygen consumption) and RincStO2 (increase rate of StO2 during the reperfusion phase, corresponding to relative hyperemia). Both are expressed in %/s. The intensity of reperfusion can be quantified by delta THI. A recent study in cardiac surgery did not show StO2 modifications under CBP but providing a small population sample and the type of monitoring used, this study might include some methodologic biais. Finally, very recently a correlation between FMD and the variation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): C/ Syndecan – 1 concentration assessment: This molecule is closely linked to glycocalyx and is considered as the most predictive marker of its integrity. Many factors might cause lesions of this structure (inflammation, hyperglycemia, CBP, etc). Its destruction causes further an impairement of endothelial function (vasoconstriction et vasodilation), mediated principally by endothelial factors. Corticoids can be considered as the most effective molecule for glycocalyx protection. Yet we will analyze syndecan - 1 as a glycocalyx marker, then endothelial markers (facteur de von Willebrandt ) and inflammation markers (CRP). ;Timepoint(s) of evaluation of this end point: The day before surgery, at anesthesia induction, at ICU admission, at 24 and 48 hours | — |
Countries
Belgium
Contacts
Public ContactAnesthésie
Hôpital Erasme
Outcome results
None listed