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Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05833828
Acronym
RAAS-HLM
Enrollment
40
Registered
2023-04-27
Start date
2023-08-24
Completion date
2025-08-31
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasoplegia, Vasoplegic Shock

Keywords

vasoplegia, vasoplegic shock, cardiopulmonary bypass, cardiac surgery

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.

Interventions

PROCEDUREon-pump surgery

the surgery will be performed on-pump

PROCEDUREoff-pump surgery

the surgery will be performed off-pump

Sponsors

Universität Münster
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Differences in plasma concentration of Aldosteronebetween induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensinogenbetween induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Reninbetween induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin Ibetween induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin converting enzyme (ACE)between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin IIbetween induction of anesthesia and immediately after surgical intervention

Secondary

MeasureTime frame
Differences in plasma concentration of Angiotensin 2-7between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3)between induction of anesthesia and immediately after surgical intervention
Incidence of vasoplegiawithin 12 hours post surgery
Cumulative dose of vasopressorswithin 12 hours post surgery
Differences in plasma concentration of Angiotensin 1-9between induction of anesthesia and immediately after surgical intervention

Countries

Germany

Contacts

Primary ContactAlexander Zarbock, MD
aki@anit.uni-muenster.de+492518347255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026