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

NCT05925348 | Unknown

• 1 other identifier: AnIt22-11
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasoplegia; Vasoplegic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Norepinephrine equivalent dose (NED)

  within 24 hours following induction of general anesthesia

Secondary Outcomes (4)

• Fluid input

  within 24 hours following induction of general anesthesia

• Fluid balance

  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

• Duration of mechanical ventilation

  within 72 hours after cardiac surgery

Interventions

Patients with cardiopulmonary bypass DIAGNOSTIC_TEST

Due to the observational design of the study, no study-specific interventions are performed. Blood samples are measured to analyze blood-levels of endotoxin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Perioperative patients

You may qualify if:

• adult patients undergoing cardiac surgery requiring CPB
• written informed consent

You may not qualify if:

• emergency surgery in the context of acute coronary syndrome
• patients with chronic inflammatory diseases of the gut
• patients receiving immunosuppressive drugs
• patients with infectious endocarditis
• patients with sepsis
• patients with chronic kidney disease with estimated glomerular filtration rate (eGFR) \<20 ml/min/1,73m²
• persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
• persons held in an institution by legal of official order -

Sponsors & Collaborators

• Universität Münster: lead

Study Sites (1)

University Hospital Münster

Münster, 48149, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Vasoplegia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Zarbock, MD

  University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine

  STUDY CHAIR

Central Study Contacts

Sadjadi, MD

CONTACT

+49-251-8347255; aki@anit.uni-muenster.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 29, 2023
• Study Start: October 2, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)