Endotoxinemia and Vasoplegia Following Cardiothoracic Surgery With Cardiopulmonary Bypass (CPB)

Study Overview
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Brief Summary
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This observational study investigates the effect of endotoxinemia on the postoperative incidence of vasoplegia or vasoplegic shock in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

Detailed Description
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Through previous research, it has been well established that cardiothoracic surgery using cardiopulmonary bypass (CPB) causes a systemic inflammatory response. This is in part due to the surgical trauma, the extracorporeal circulation and factors that come with it (e.g. blood contact with foreign surfaces, mechanical stress etc.), and ischemia. This inflammatory response is a key contributor to the incidence of vasoplegia and vasoplegic shock following these types of surgery - a common complication that in turn causes significant morbidity and mortality. Over the years, many factors that contribute to this reaction have been discussed. One potential explanation is the release of endotoxin into the bloodstream during CPB. Endotoxin is a molecule that is a part of bacteria which are native to the human gut. In healthy subjects, cell-barriers prevent release of relevant amounts of endotoxin into the blood stream. During major interventions, and especially during cardiac surgery with CPB, this barrier function is impeded, allowing endotoxin levels to rise and potentially exert detrimental effects. While previous studies have indicated that endotoxin may in fact be released into the bloodstream in significant concentrations, and there are some mechanistic explanations to how endotoxin may contribute to the resulting inflammation and vasoplegia, available studies have been small and the evidence is inconclusive. This study aims to show whether different blood-levels of endotoxin are associated with vasoplegia and vasoplegic shock in patients undergoing cardiac surgery with CPB.

Official Title
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Effect of Endotoxinemia on the Incidence of Postoperative Vasoplegia or Vasoplegic Shock Following Cardiothoracic Surgery Using Cardiopulmonary Bypass

Conditions
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Vasoplegia, Vasoplegic Shock

Intervention / Treatment
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* Diagnostic Test: Patients with cardiopulmonary bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients undergoing cardiac surgery requiring CPB written informed consent Exclusion Criteria: emergency surgery in the context of acute coronary syndrome patients with chronic inflammatory diseases of the gut patients receiving immunosuppressive drugs patients with infectious endocarditis patients with sepsis patients with chronic kidney disease with estimated glomerular filtration rate (eGFR) <20 ml/min/1,73m² persons with any kind of dependency on the investigator or employed by the institution responsible or investigator persons held in an institution by legal of official order -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Patients with cardiopulmonary bypass|Due to the observational design of the study, no study-specific interventions are performed. Blood samples are measured to analyze blood-levels of endotoxin|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Norepinephrine equivalent dose (NED) |  | within 24 hours following induction of general anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid input |  | within 24 hours following induction of general anesthesia | 
| Fluid balance |  | within 24 hours following induction of general anesthesia | 
| Occurence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria |  | 72 hours after cardiac surgery | 
| Duration of mechanical ventilation |  | within 72 hours after cardiac surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endotoxin, cardiopulmonary bypass (CBP), Vasoplegia, Vasoplegic shock