Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to evaluate whether adding angiotensin II to the standard of care is superior compared to the standard of care alone with respect to kidney damage (personalized approach) after cardiac surgery.


Clinical Trial Description

Vasoplegic syndrome is a form of distributive shock that is characterized by low arterial pressure with reduced systemic vascular resistance and normal or elevated cardiac output that occurs in 5 to 25% of patients undergoing cardiac surgery. Patients with vasoplegic shock after cardiac surgery are at higher risk of organ failure, including acute kidney injury (AKI). Postsurgical AKI is associated with several adverse outcomes. Attempts to prevent AKI have largely been futile so far. Prior studies often started with the interventions after an AKI event, when a decline of kidney function (i.e. glomerular filtration rate) was already established. Application of norepinephrine is currently considered as the first-line therapy for vasoplegic shock, but all catecholamines have adverse effects, including myocardial ischemia and arrhythmias. In a recent observational trial, we demonstrated that there is a dysregulation in the renin-angiotensin-aldosterone system (RAAS) likely caused by a reduced angiotensin-converting enzyme (ACE) activity after cardiac surgery. Elevated renin levels identified patients at risk for AKI and were associated with cardiovascular instability and increased AKI rate after cardiac surgery. Furthermore, elevated renin levels could be used to identify high-risk patients for cardiovascular instability and AKI who would benefit from timely intervention with angiotensin II that could improve their outcomes. Therefore, the application of angiotensin II to treat a postoperative hypotension would mean a hormone substitution.Shock after cardiac surgery is associated with increased mortality. Cardiopulmonary bypass (CPB) represents a common clinical setting of sympathetic nervous system activation and cardiovascular instability. Vasoplegia is a form of distributive shock that is characterized by low arterial pressure with reduced systemic vascular resistance and normal or elevated cardiac output. It occurs in 5 to 25% of patients undergoing cardiac surgery. Patients with vasoplegia after cardiac surgery are at higher risk of organ failure, including AKI, and have an increased mortality rate and longer hospital length of stay. Clinical trials focusing on septic patients suggest that AT-II is a potent vasopressor. However, no human data exist whether the application of AT-II in cardiac surgery patients with y hyperreninemia high-risk patients identified by renin levels (individualized approach) reduces kidney damage and improves kidney function after cardiac surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05199493
Study type Interventional
Source Westfälische Wilhelms-Universität Münster
Contact
Status Completed
Phase Phase 3
Start date December 27, 2021
Completion date March 19, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT04051021 - Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients N/A
Recruiting NCT04604886 - The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients N/A
Recruiting NCT04075981 - Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF) Phase 3
Completed NCT04062396 - Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction N/A
Recruiting NCT04709705 - DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS) Phase 2/Phase 3
Not yet recruiting NCT05563662 - SURgical Registry of ENDocarditis EuRope
Withdrawn NCT03289104 - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX N/A
Completed NCT04199039 - Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction N/A
Completed NCT03563196 - Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
Completed NCT02964026 - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients N/A
Completed NCT02471001 - The Levels of Anaesthetics in Heart Muscle During Heart Surgery N/A
Completed NCT02325726 - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery. N/A
Completed NCT01246947 - Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation N/A
Completed NCT01151254 - Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation N/A
Completed NCT00996099 - Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients N/A
Completed NCT00821262 - Sevoflurane in Cardiac Surgery Phase 4
Completed NCT00617955 - Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates N/A
Completed NCT00336466 - The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS) Phase 2
Completed NCT00337805 - Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery Phase 2/Phase 3