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

Recruiting

• Conditions: Vasoplegic Shock; Vasoplegia

• Registration Number: NCT05925348
• Lead Sponsor: Universität Münster

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.

Study Timeline

• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-29
• Study Start: 2023-10-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Norepinephrine equivalent dose (NED)	within 24 hours following induction of general anesthesia

Secondary Outcome Measures

Name	Time	Method
Fluid balance	within 24 hours following induction of general anesthesia
Duration of mechanical ventilation	within 72 hours after cardiac surgery
Fluid input	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

Trial Locations

Locations (1)

University Hospital Münster; 🇩🇪 Münster, Germany