Clinical trial NCT05925348: Endotoxinemia and Vasoplegia Following Cardiothoracic Surgery With Cardiopulmonary Bypass (CPB)
Official title: Effect of Endotoxinemia on the Incidence of Postoperative Vasoplegia or Vasoplegic Shock Following Cardiothoracic Surgery Using Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vasoplegia
Vasoplegic Shock
Keywords: Endotoxin
cardiopulmonary bypass (CBP)
Vasoplegia
Vasoplegic shock
Lead sponsor: Universität Münster
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Perioperative patients

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. adult patients undergoing cardiac surgery requiring CPB
2. written informed consent

Exclusion Criteria:

1. emergency surgery in the context of acute coronary syndrome
2. patients with chronic inflammatory diseases of the gut
3. patients receiving immunosuppressive drugs
4. patients with infectious endocarditis
5. patients with sepsis
6. patients with chronic kidney disease with estimated glomerular filtration rate (eGFR) \<20 ml/min/1,73m²
7. persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
8. persons held in an institution by legal of official order -

Primary outcomes:
measure: Norepinephrine equivalent dose (NED)
timeFrame: within 24 hours following induction of general anesthesia
Secondary outcomes:
measure: Fluid input
timeFrame: within 24 hours following induction of general anesthesia
measure: Fluid balance
timeFrame: within 24 hours following induction of general anesthesia
measure: Occurence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
timeFrame: 72 hours after cardiac surgery
measure: Duration of mechanical ventilation
timeFrame: within 72 hours after cardiac surgery
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Münster
Study officials:
affiliation: University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
name: Alexander Zarbock, MD
role: STUDY_CHAIR
References: