An observational study in Vasoplegia and Vasoplegic Shock, sponsored by Universität Münster. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Universität Münster · Observational
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
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.
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's planned enrollment of 40 is below the median of 200 across 19 observational studies indexed under Vasoplegia.
Browse Vasoplegia studies →Universität Münster is the lead sponsor of 30 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
University Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Procedure: on-pump surgery
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).
Procedure: off-pump surgery
the surgery will be performed "on-pump"
the surgery will be performed "off-pump"
Differences in plasma concentration of Angiotensinogen
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Renin
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin I
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin converting enzyme (ACE)
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin II
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Aldosterone
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin 1-9
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Angiotensin 2-7
Time frame: between induction of anesthesia and immediately after surgical intervention
Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3)
Time frame: between induction of anesthesia and immediately after surgical intervention
Incidence of vasoplegia
Time frame: within 12 hours post surgery
Cumulative dose of vasopressors
Time frame: within 12 hours post surgery
Plan to share: No
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