Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

Vasoplegia Clinical Trial

— RAAS-HLM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833828
• Other study ID #: AnIt22-08
• Status: Recruiting
• Start date: August 24, 2023
• Est. completion date: February 2025

Study information

• Verified date: December 2023
• Source: Universität Münster
• Contact: Alexander Zarbock, MD
• Phone: +492518347255
• Email: aki[@]anit.uni-muenster.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vasoplegia

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine	Münster

Sponsors (1)

Lead Sponsor	Collaborator
Universität Münster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in plasma concentration of Angiotensinogen		between induction of anesthesia and immediately after surgical intervention
Primary	Differences in plasma concentration of Renin		between induction of anesthesia and immediately after surgical intervention
Primary	Differences in plasma concentration of Angiotensin I		between induction of anesthesia and immediately after surgical intervention
Primary	Differences in plasma concentration of Angiotensin converting enzyme (ACE)		between induction of anesthesia and immediately after surgical intervention
Primary	Differences in plasma concentration of Angiotensin II		between induction of anesthesia and immediately after surgical intervention
Primary	Differences in plasma concentration of Aldosterone		between induction of anesthesia and immediately after surgical intervention
Secondary	Differences in plasma concentration of Angiotensin 1-9		between induction of anesthesia and immediately after surgical intervention
Secondary	Differences in plasma concentration of Angiotensin 2-7		between induction of anesthesia and immediately after surgical intervention
Secondary	Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3)		between induction of anesthesia and immediately after surgical intervention
Secondary	Incidence of vasoplegia		within 12 hours post surgery
Secondary	Cumulative dose of vasopressors		within 12 hours post surgery