Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery (RAAS-HLM)

Universität Münster

Status: Enrolling

Conditions: Vasoplegia; Vasoplegic Shock

Treatments: Procedure: off-pump surgery; Procedure: on-pump surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05833828

AnIt22-08

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

on-pump coronary artery bypass graft surgery

Description:

Due to the observational design of the study, no study-specific interventions are performed. Except for the above mentioned laboratory analyses, the treatment of the patients is completely guided by the responsible ICU physicians. Study participation does not influence the determination of surgical procedure (on- vs off-pump).

Treatment:

Procedure: on-pump surgery

off-pump coronary artery bypass graft surgery

Description:

Due to the observational design of the study, no study-specific interventions are performed. Except for the above mentioned laboratory analyses, the treatment of the patients is completely guided by the responsible ICU physicians. Study participation does not influence the determination of surgical procedure (on- vs off-pump).

Treatment:

Procedure: off-pump surgery