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Recruiting NCT05833828

Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

— Observational Vasoplegia Vasoplegic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: on-pump surgery, off-pump surgery.
Who it may be relevant to
Registry conditions: Vasoplegia, Vasoplegic Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

This study investigates the question of whether there are differences in the plasma concentration of hormones of the RAAS-axis between patients undergoing on-pump cardiac surgery and those receiving off-pump surgery

Detailed description

In patients undergoing cardiac surgery, the occurrence of vasoplegia or vasoplegic shock is a common and sometimes very severe complication. Although there are multiple factors that may affect the incidence and severity of vasoplegia, it remains unclear which role the use of cardiopulmonary bypass may play in the pathogenesis of this complication. The heart normally pumps blood through the lungs where the blood primarily gets oxygenated. However, it is also known that pulmonary blood flow is also essential for the activation of various hormones, some of which are central to the regulation of vascular tension and blood pressure. If the pulmonary circulation is bypassed, as is the case in on-pump cardiac surgery, it is likely that the resulting differential activity of hormones may cause or contribute to the incidence of vasoplegia. This study aims to show whether cardiopulmonary bypass leads to the differential regulation of hormones of the renin-angiotensin-aldosterone-system which could explain why some patients suffer from vasoplegia or vasoplegic shock following such procedures.

Interventions

  • Procedure on-pump surgery
    the surgery will be performed "on-pump"
  • Procedure off-pump surgery
    the surgery will be performed "off-pump"

Primary outcome measures

  • Differences in plasma concentration of Angiotensinogen [Time frame: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Renin [Time frame: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Angiotensin I [Time frame: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Angiotensin converting enzyme (ACE) [Time frame: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Angiotensin II [Time frame: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Aldosterone [Time frame: between induction of anesthesia and immediately after surgical intervention]
Secondary outcome measures (5)
  • Differences in plasma concentration of Angiotensin 1-9 [Time frame: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Angiotensin 2-7 [Time frame: between induction of anesthesia and immediately after surgical intervention]
  • Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3) [Time frame: between induction of anesthesia and immediately after surgical intervention]
  • Incidence of vasoplegia [Time frame: within 12 hours post surgery]
  • Cumulative dose of vasopressors [Time frame: within 12 hours post surgery]

Eligibility criteria

Inclusion criteria

  • adult patients undergoing on- or off-pump coronary artery bypass graft surgery
  • written informed consent

Exclusion criteria

  • emergency surgery in the context of acute coronary syndrome
  • ACE-inhibitor or Angiotensin 1 (AT1)-receptor-blocker intake that was not paused on the day of surgery
  • Chronic kidney disease with estimated glomerular filtration rate (eGFR)<30ml/min/1.73m²
  • Severe structural lung disease (asbestosis, silicosis, severe sarcoidosis, tuberculosis, severe emphysema, chronic obstructive pulmonary disease (COPD) Gold 3-4, lung fibrosis)
  • Chronic pulmonary hypertension
  • Pregnancy or breastfeeding
  • Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
  • Persons held in an institution by legal or official order

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 2 centers
  • Deutsches Herzzentrum der Charité — Berlin
  • University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pai — Münster

Identifiers

NCT: NCT05833828 · AnIt22-08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗