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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05925348
Enrollment
200
Registered
2023-06-29
Start date
2023-10-02
Completion date
2025-01-31
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasoplegia, Vasoplegic Shock

Keywords

Endotoxin, cardiopulmonary bypass (CBP), Vasoplegia, Vasoplegic shock

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.

Interventions

DIAGNOSTIC_TESTPatients 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

Sponsors

Universität Münster
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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 -

Design outcomes

Primary

MeasureTime frame
Norepinephrine equivalent dose (NED)within 24 hours following induction of general anesthesia

Secondary

MeasureTime frame
Fluid inputwithin 24 hours following induction of general anesthesia
Fluid balancewithin 24 hours following induction of general anesthesia
Occurence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria72 hours after cardiac surgery
Duration of mechanical ventilationwithin 72 hours after cardiac surgery

Countries

Germany

Contacts

Primary ContactSadjadi, MD
aki@anit.uni-muenster.de+49-251-8347255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026