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NCT Number: NCT05833828

Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum der Charité, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

on-pump surgery

Procedure

the surgery will be performed "on-pump"

off-pump surgery

Procedure

the surgery will be performed "off-pump"

Primary outcomes

  1. Differences in plasma concentration of Angiotensinogen

    Time frame: between induction of anesthesia and immediately after surgical intervention

  2. Differences in plasma concentration of Renin

    Time frame: between induction of anesthesia and immediately after surgical intervention

  3. Differences in plasma concentration of Angiotensin I

    Time frame: between induction of anesthesia and immediately after surgical intervention

  4. Differences in plasma concentration of Angiotensin converting enzyme (ACE)

    Time frame: between induction of anesthesia and immediately after surgical intervention

  5. Differences in plasma concentration of Angiotensin II

    Time frame: between induction of anesthesia and immediately after surgical intervention

  6. Differences in plasma concentration of Aldosterone

    Time frame: between induction of anesthesia and immediately after surgical intervention

Secondary outcomes

  1. Differences in plasma concentration of Angiotensin 1-9

    Time frame: between induction of anesthesia and immediately after surgical intervention

  2. Differences in plasma concentration of Angiotensin 2-7

    Time frame: between induction of anesthesia and immediately after surgical intervention

  3. Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3)

    Time frame: between induction of anesthesia and immediately after surgical intervention

  4. Incidence of vasoplegia

    Time frame: within 12 hours post surgery

  5. Cumulative dose of vasopressors

    Time frame: within 12 hours post surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Zarbock, MD

CONTACT

[email protected]

+492518347255

Sponsors and collaborators

Lead sponsor

Universität Münster

Other

Registry information

Official study title

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

Acronym: RAAS-HLM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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