Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539234
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Angiotensin II Stress Test Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Angiotensin II Stress Test Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II in Relation to Hemodynamic Response to Treatment With Angiotensin II
Status:
RECRUITING
Status Verified Date:
2024-08
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:
TENSINTEST
Brief Summary:
Shock is a life-threatening condition which can cause multiple organ failure and even death One characteristic of shock is low blood pressure which is managed with drugs called vasopressors Most frequently used vasopressors are noradrenaline vasopressin and recently also angiotensin II Angiotensin II is present in the body and has a physiological role in maintaining blood pressure in healthy persons Renin is an enzyme and a key factor in angiotensin II production in the body In patients with shock there is a lack of angiotensin II and an excess of renin in the body Due to the literature renin has the potential to be a marker of severity of shock Synthetic angiotensin II is used in patients with shock in whom we cannot normalize the blood pressure with noradrenaline and vasopressin Regarding scientific data the use of synthetic angiotensin II reduces the dose of noradrenaline and vasopressin and the incidence of acute kidney injury The aim of our study is to find out what is the relation between the concentration of renin before and 6 hours after the start of using angiotensin II in patients with shock and their clinical outcome Since not all patients with shock are responding to angiotensin II the aim of our study is also to find out which patients could benefit most from synthetic angiotensin II
Detailed Description:
In patients with distributive shock 18 years with noradrenaline 03 mcgkgmin and vasopressin 003 IEmin not achieving an appropriate mean arterial pressure 65-85 mmHg an angiotensin II infusion will be started at 20 ngkgmin and after that adjusted to a max dose of 40 ngkgmin if needed Before the infusion and 6 hours after the start of angiotensin II infusion a blood sample will be drawn to determine the renin concentration The primary outcome will be organ failure free days and ICU free days Secondary outcome will be the need for vasopressors dialysis mechanical ventilation trend of renin concentration
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