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

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.

Study Overview

• Status: Recruiting
• Conditions: Vasoplegia; Vasoplegic Shock
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Sadjadi, MD; Phone Number: +49-251-8347255; Email: aki@anit.uni-muenster.de

Study Locations

• Germany
  • Münster, Germany, 48149
    • Recruiting
    • University Hospital Münster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Perioperative patients

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Norepinephrine equivalent dose (NED)	within 24 hours following induction of general anesthesia

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurence of Acute Kidney Injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria	72 hours after cardiac surgery
Fluid input	within 24 hours following induction of general anesthesia
Fluid balance	within 24 hours following induction of general anesthesia
Duration of mechanical ventilation	within 72 hours after cardiac surgery

Collaborators and Investigators

• Sponsor: Westfälische Wilhelms-Universität Münster
• Investigators: Study Chair: Alexander Zarbock, MD, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Endotoxin; Vasoplegia; cardiopulmonary bypass (CBP); Vasoplegic shock
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Shock; Vasoplegia
• Other Study ID Numbers: AnIt22-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No