Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615102
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Reducing Cardiac-surgery Associated Acute Kidney Injury Occurence by Administering Angiotensin II
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Angiotensin II Versus Noradrenaline Trial for Hypotension Management to Reduce Cardiac-surgery Associated Acute Kidney Injury PAN-AKI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAN-AKI
Brief Summary:
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 moderatesevere 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 moderatesevere AKI in this context The intervention aims to address this gap by evaluating angiotensin IIs impact compared to norepinephrine
Detailed Description:
Acute kidney injury AKI is defined by changes in serum creatinine andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None