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

Vasoplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925348
• Other study ID #: AnIt22-11
• Status: Recruiting
• Start date: October 2, 2023
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: Universität Münster
• Contact: Sadjadi, MD
• Phone: +49-251-8347255
• Email: aki[@]anit.uni-muenster.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Shock
• Vasoplegia

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Universität Münster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Norepinephrine equivalent dose (NED)		within 24 hours following induction of general anesthesia
Secondary	Fluid input		within 24 hours following induction of general anesthesia
Secondary	Fluid balance		within 24 hours following induction of general anesthesia
Secondary	Occurence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria		72 hours after cardiac surgery
Secondary	Duration of mechanical ventilation		within 72 hours after cardiac surgery