RecruitingNot Applicable

Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

Germany40 participantsStarted 2023-08-24

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Differences in plasma concentration of Angiotensinogen

Timeframe: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Renin

Timeframe: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Angiotensin I

Timeframe: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Angiotensin converting enzyme (ACE)

Timeframe: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Angiotensin II

Timeframe: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Aldosterone

Timeframe: between induction of anesthesia and immediately after surgical intervention

Trial details

NCT IDNCT05833828

SponsorUniversität Münster

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05

Contact for this trial

Alexander Zarbock, MD

+492518347255 aki@anit.uni-muenster.de

View on ClinicalTrials.gov More Vasoplegia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Differences in plasma concentration of Angiotensinogen

Timeframe: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Renin

Timeframe: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Angiotensin I

Timeframe: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Angiotensin converting enzyme (ACE)

Timeframe: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Angiotensin II

Timeframe: between induction of anesthesia and immediately after surgical intervention

Differences in plasma concentration of Aldosterone

Timeframe: between induction of anesthesia and immediately after surgical intervention