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| Name | Class |
|---|---|
| University Hospital, Rouen | OTHER |
| University Hospital, Lille | OTHER |
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Cardiac surgery is a high-risk surgery and is associated with a rate of postoperative adverse outcomes. Like many others major surgery, cardiac surgery procedures induce a proinflammatory phase usually counterbalanced with an immunosuppressive phase so the immune response remained balanced.
In some cases, the immune response might be dysregulated with a more pronounced pro inflammatory state that compromises organ perfusion and with the occurrence of organ failure. From a mechanistic approach, the relationship between organ failure is complex and multifactorial with a high level of proinflammatory cytokines, a decrease in microcirculation, an endothelial dysfunction and an activation of coagulation and over. The clinical expression is an increase in vasopressor exposure and dose, an increase in mortality and in adverse outcomes with a predominance of acute kidney injury.
Various therapies have been assessed to manage cardiac surgery related sepsis including glucocorticoid therapy. Briefly, two major randomized trials assessed glucocorticoid therapy solely in scheduled cardiac surgery with cardiopulmonary bypass. No clinical benefit was demonstrated in term of reduction in postoperative mortality or adverse outcomes. Since, data support that the selection of patients at risk is crucial to demonstrate such a strategy. Indeed, data support that surprisingly some patients will have a very light immune response reflected by a low pro inflammatory cytokine.
The hypothesis is that the combination glucocorticoid and fludrocortisone could decrease adverse outcomes in selected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydrocortisone plus fludrocortisone | Experimental |
|
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| placebo of hydrocortisone plus fludrocortisone | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocortisone plus fludrocortisone | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Variation of acute kidney injury occurence between both groups | up to 7 days | |
| Variation of postoperative pulmonary complication occurrence between both groups | up to 7 days | |
| Variation of number of norepinephrine requirement between both groups | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| variation of postoperative atrial fibrillation occurence between both groups | Postoperative atrial fibrillation: defined as a new-onset arrhythmia within 7 days after surgery, documented by an electrocardiogram showing absence of P waves and narrow, irregular QRS complexes | up to 7 days |
| variation of myocardial infarction occurence between both groups |
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Inclusion Criteria:
Age > 18 years.
Patient at intermediate/high risk (EuroSCORE II > 4%).
Patient admitted for scheduled cardiac surgery:
Patient undergoing cardiopulmonary bypass (CPB).
Informed consent signed by the patient.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe Beyls, MD | Contact | (33)3 22 08 78 66 | Beyls.christophe@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Amiens | Recruiting | Amiens | 80480 | France |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D005438 | Fludrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| placebo of hydrocortisone plus fludrocortisone | Drug |
|
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Myocardial infarction: defined according to the Fourth Universal Definition |
| up to 7 days |
| variation of stroke occurence between both groups | Stroke: defined as the sudden onset of a neurological deficit confirmed by brain imaging | up to 7 days |
| Variation of total amount of norepinephrine between both groups | The total amount of norepinephrine will be expressed in milligrams and will correspond to the cumulative dose administered from ICU admission until the 7th postoperative day. | up to 7 days |
| variation of occurrence of glucocorticoid side effect between both groups | glucocorticoid side effects are hyperglycemia, hypernatremia and infections | up to 7 days |
| Variation of 28-day mortality between both groups | at 28 days |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |