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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05925348
Other study ID # AnIt22-11
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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 -

Study Design


Related Conditions & MeSH terms


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
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