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

Sponsor

Westfälische Wilhelms-Universität Münster (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05925348

Collaborator

(none)

200

Enrollment

18.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vasoplegia Vasoplegic Shock	Diagnostic Test: Patients with 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Outcome Measures

Primary Outcome Measures

Norepinephrine equivalent dose (NED) [within 24 hours following induction of general anesthesia]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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 -