A Phase 3 interventional study of Angiotensin II and Noradrenalin in Cardiac Surgery and Vasoplegia, sponsored by Universität Münster. Recruiting at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Universität Münster · Phase 3, Interventional, and Treatment
The study intervention focuses on exploring the use of angiotensin II as a primary vasopressor compared to norepinephrine in cardiac surgery patients to investigate whether angiotensin II can reduce the occurrence of moderate/severe acute kidney injury (AKI). Despite its potential, as suggested by trials involving surgical patients, there is currently no human data confirming its effectiveness in preventing moderate/severe AKI in this context. The intervention aims to address this gap by evaluating angiotensin II's impact compared to norepinephrine.
Acute kidney injury (AKI) is defined by changes in serum creatinine and/or urine output, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. In cardiac surgical patients, the AKI rate is up to 30%, with 1-2% of the patients requiring renal replacement therapy (RRT). Cardiac-surgery associated AKI (CSA-AKI) is associated with increased short- and long-term morbidity and mortality as well as increased hospital costs.
Shock after cardiac surgery is also associated with increased mortality. In the context of cardiac surgery with the use of the cardiopulmonary bypass (CPB), sympathetic nervous system activation and cardiovascular instability are common sequelae. Vasoplegic syndrome is a form of distributive shock that is characterized by low arterial pressure, reduced systemic vascular resistance, and normal or elevated cardiac output. It occurs in 5 to 25% of the patients undergoing cardiac surgery. Patients with vasoplegic shock are at higher risk of organ failure, including AKI, and show increased mortality rates and longer hospital length of stays. Currently, norepinephrine is the established first-line vasopressor for the treatment of vasoplegic shock, but all vasopressors have adverse effects, including myocardial ischemia and arrhythmias. Moreover, in vasoplegic situations, vascular smooth muscle cells may become unresponsive to vasopressors. The underlying mechanisms are complex and include adrenoceptor desensitization, increased nitric oxide (NO) synthesis, activation of adenosine triphosphate-sensitive K+ channels, and vasopressin and corticosteroid deficiency.
Physiologically, the renin-angiotensin-aldosterone system (RAAS) is a hormone system that plays a central role in regulating blood pressure and fluid balance, glomerular filtration rate, and electrolyte levels. Renin, a proteolytic enzyme released by juxtaglomerular cells in response to hypotension, decreases sodium delivery to the distal tubule, activates the sympathetic nervous system, and cleaves angiotensinogen to angiotensin I which is a precursor of the vasoactive angiotensin II. RAAS is regulated by a biofeedback loop. Angiotensin II generation inhibits renin release, whereas renin levels increase when there is insufficient activation of the angiotensin II type 1 receptor. Administration of angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB) and reduced angiotensin II generation cause a corresponding increase in renin levels.
Despite numerous clinical trials using several interventions, a reliable means to prevent AKI remains elusive. Clinical trials focusing on surgical patients suggest that angiotensin II is a potent vasopressor. However, no human data exist whether the application of angiotensin II as a primary vasopressor reduces the occurrence of AKI in patients undergoing cardiac surgery.
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's planned enrollment of 1,022 is above the median of 110 across 27 interventional 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.
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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.
Elevated risk of AKI as predicted by a score ≥ 1.5 on the following scale:
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous infusion through a central line according to the patient's situation. Target medium arterial pressure (MAP): \>65mmHg
Drug: Angiotensin II
Intravenous infusion through a central line according to the patient's situation. Target medium arterial pressure (MAP): \>65mmHg
Drug: Noradrenalin
Intravenous infusion through a central line according to the patient's situation. Once an infusion is established, the dose will be titrated as frequently as every 5 minutes, as needed, depending on the patient's condition and target MAP.
Intravenous infusion through a central line according to the patient's situation. Once an infusion is established, the dose will be titrated as frequently as every 5 minutes, as needed, depending on the patient's condition and target MAP.
Rate of AKI KDIGO stage 2 or 3 or death within 72 hours after end of cardiac surgery.
Time frame: 72 hours after end of surgery
Major Adverse Kidney Events (MAKE90)
1\. MAKE90 (consisting of mortality, dialysis within 90 days, persistent renal dysfunction (defined as serum creatinine ≥ 2x compared to baseline value at day 90)
Time frame: 90 after cardiac surgery
Severity of Acute Kidney Injury
Number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3)
Time frame: 72 hours after cardiac surgery
Development or progression of chronic kidney injury
Development or progression of chronic kidney disease based on albuminuria, urine creatinine (and the respective ratio) and serum creatinine or death within 120 days
Time frame: 90 to 120 days after cardiac surgery
Use of additional open-label vasopressors or inotropes
Time frame: within 72 h after cardiac surgery
Volume of fluid application within the first 72 hours
Time frame: within 72 h after cardiac surgery
Volume status
Time frame: within 72 h after cardiac surgery
Time to death
Time frame: 30 days after cardiac surgery
Time to death
Time frame: 60 days after cardiac surgery
Time to death
Time frame: 90 days after cardiac surgery
Days alive and in (index) ICU
Time frame: From start of intervention until 60 days after cardiac surgery
Days alive and in (index) Hospital
Time frame: From start of intervention until 60 days after cardiac surgery
Incidence of adverse events (AEs) and serious AEs (SAEs)
Time frame: From start of intervention until discharge / day 7
Occurence of AKI according to the KDIGO criteria
Time frame: From start of intervention unto 72 hours after cardiac surgery
Number of patients with persistent renal dysfunction
defined as serum creatinine ≥ 2x compared to baseline value
Time frame: On day 90 after cardiac surgery
Number of patients with dialysis renal/replacement therapy
Time frame: On day 90 after cardiac surgery
Mortality
Time frame: On day after cardiac surgery
Dose of vasopressors
Time frame: from start of surgery unto 72 hours after cardiac surgery
Days alive and free of mechanical ventilation until day 60
Time frame: From start of intervention unto 60 days after cardiac surgery
Duration of mechanical ventilation
Time frame: From start of intervention unto discharge from hospital or day seven after cardiac surgery (whatever comes first)
Days alive and free of vasopressors and mechanical ventilation
Time frame: From start of intervention unto 60 days after cardiac surgery
Number of days alive and free of vasopressors and mechanical ventilation
Time frame: From start of intervention until 28 days after cardiac surgery
Change in total and individual organ failure scores through 72 hours
Sequential Organ Failure Assessment (SOFA) score
Time frame: Start of intervention and 72 hours after cardiac surgery
Duration of renal replacement therapy
Time frame: From start of intervention unto 90 days after cardiac surgery
Number of patients with renal replacement therapy
Time frame: Day 90 after cardiac surgery
Creatinine clearance on day one after cardiac surgery
Time frame: 24 hours after cardiac surgery
Incidence of documented new onset atrial fibrillation
Time frame: From end of surgery to hospital discharge
Occurrence of transient (< 48 hours) and persistent (≥ 48 hours) AKI
Time frame: From start of intervention to hospital discharge
Identification and evaluation of biomarkers
Time frame: From start of intervention to 48 hours after cardiac surgery
Plan to share: Yes — Deidentified patient data will be available up to 3 years after original manuscript publication to researchers with methodologically sound proposals approved by the principal investigator. Supporting Materials:
Supporting information: Study protocol, Informed consent form
Time frame: Up to 3 years after original manuscript publication
Access criteria: Available to researchers with methodologically sound proposals approved by the principal investigator.
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Studies of the drug tested here: Angiotensin II
Universität Münster