Clinical trial NCT05833828: Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery
Official title: Differences in Plasma Concentration of RAAS-axis Hormones in Patients Undergoing Cardiac Surgery With or Without Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vasoplegia
Vasoplegic Shock
Keywords: vasoplegia
vasoplegic shock
cardiopulmonary bypass
cardiac surgery
Lead sponsor: Universität Münster
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University Hospital

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. emergency surgery in the context of acute coronary syndrome
2. ACE-inhibitor or Angiotensin 1 (AT1)-receptor-blocker intake that was not paused on the day of surgery
3. Chronic kidney disease with estimated glomerular filtration rate (eGFR)\<30ml/min/1.73m²
4. Severe structural lung disease (asbestosis, silicosis, severe sarcoidosis, tuberculosis, severe emphysema, chronic obstructive pulmonary disease (COPD) Gold 3-4, lung fibrosis)
5. Chronic pulmonary hypertension
6. Pregnancy or breastfeeding
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 or official order

Primary outcomes:
measure: Differences in plasma concentration of Angiotensinogen
timeFrame: between induction of anesthesia and immediately after surgical intervention
measure: Differences in plasma concentration of Renin
timeFrame: between induction of anesthesia and immediately after surgical intervention
measure: Differences in plasma concentration of Angiotensin I
timeFrame: between induction of anesthesia and immediately after surgical intervention
measure: Differences in plasma concentration of Angiotensin converting enzyme (ACE)
timeFrame: between induction of anesthesia and immediately after surgical intervention
measure: Differences in plasma concentration of Angiotensin II
timeFrame: between induction of anesthesia and immediately after surgical intervention
measure: Differences in plasma concentration of Aldosterone
timeFrame: between induction of anesthesia and immediately after surgical intervention
Secondary outcomes:
measure: Differences in plasma concentration of Angiotensin 1-9
timeFrame: between induction of anesthesia and immediately after surgical intervention
measure: Differences in plasma concentration of Angiotensin 2-7
timeFrame: between induction of anesthesia and immediately after surgical intervention
measure: Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3)
timeFrame: between induction of anesthesia and immediately after surgical intervention
measure: Incidence of vasoplegia
timeFrame: within 12 hours post surgery
measure: Cumulative dose of vasopressors
timeFrame: within 12 hours post surgery
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Münster
country: Germany
facility: University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
Study officials:
affiliation: University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine
name: Alexander Zarbock, MD
role: STUDY_CHAIR
References: