Actively Recruiting

Age: 18Years +
All Genders
ID05833828

Differences in Plasma Concentration of RAAS-axis Hormones in Patients Undergoing Cardiac Surgery With or Without Cardiopulmonary Bypass

Led by Universität Münster · Updated on 2024-12-12

40

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand whether there are differences in hormone levels related to the renin-angiotensin-aldosterone system (RAAS) in patients undergoing cardiac surgery with or without the use of a heart-lung machine (cardiopulmonary bypass). The study focuses on the complication called vasoplegia or vasoplegic shock, which can occur after cardiac surgery and may be influenced by how the surgery is performed. It seeks to clarify the role that bypassing the lungs during surgery plays in regulating hormones that control blood vessel tension and blood pressure. The study observes two groups of patients: those having coronary artery bypass graft surgery with the heart-lung machine (on-pump) and those without it (off-pump). No specific treatments or interventions are assigned by the study; instead, medical care is managed by intensive care unit physicians as usual. Blood samples will be collected before anesthesia and immediately after surgery to measure hormone levels related to RAAS. Participants will be involved during the surgical period where plasma concentrations of various RAAS hormones are measured and compared between the two surgery types. The study also monitors the occurrence of vasoplegia and the amount of vasopressors (medications to raise blood pressure) used within 12 hours after surgery. The total participation period encompasses the surgical procedure and immediate postoperative monitoring. This observational approach aims to provide insight into the hormonal changes linked to surgical methods and their connection to vasoplegia.

CONDITIONS

Brief Title

Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients undergoing on- or off-pump coronary artery bypass graft surgery
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Emergency surgery in the context of acute coronary syndrome
  • Taking ACE-inhibitor or Angiotensin 1 (AT1)-receptor-blocker not paused on the day of surgery
  • Chronic kidney disease with eGFR less than 30 ml/min/1.73m²
  • Severe structural lung disease such as asbestosis, silicosis, severe sarcoidosis, tuberculosis, severe emphysema, COPD Gold 3-4, or lung fibrosis
  • Chronic pulmonary hypertension
  • Pregnancy or breastfeeding
  • Persons dependent on the investigator or employed by the institution responsible or investigator
  • Persons held in an institution by legal or official order

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo coronary artery bypass graft surgery either with cardiopulmonary bypass (on-pump) or without it (off-pump). Blood samples are collected from anesthesia induction until immediately after surgery to measure hormone levels related to vascular tension and blood pressure.

1 visit (in-person)

Post-operative Follow-up

Duration - 12 hours post surgery

Participants are monitored for the incidence of vasoplegia and cumulative vasopressor use within 12 hours after surgery.

Continuous monitoring during hospital stay

Trial Site Locations

Total: 2 locations

1

Deutsches Herzzentrum der Charité

Berlin, Germany, 13353

Actively Recruiting

2

University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine

Münster, Germany, 48149

Actively Recruiting

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Research Team

A

Alexander Zarbock, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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