Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03733145
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2018-11-05
Brief Title:
Angiotensin II in General Anesthesia
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Dose Finding Trial for Angiotensin II in Hypertensive Adults on Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Anesthesia-Mediated Hypotension
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypotension in adult patients undergoing general anesthesia is common This can lead to hypoperfusion of vital organs organ damage and states of increased metabolic duress This may be worse in patients with underlying essential hypertension and worse in patients taking Angiotensin Converting Enzyme Inhibitors ACE and Angiotensin Receptor Blockers ARBs Intravenous IV administration of Ang II may be an effective treatment of hypotension in this patient population
Detailed Description:
Hypotension in adult patients undergoing general anesthesia is common Many of the bodys normal mechanisms to maintain adequate blood pressure in the non-anesthetized state are significantly altered by anesthetic agents which may lead to hypotension This can lead to hypoperfusion of vital organs organ damage and states of increased metabolic duress In response to this it has become standard of care to attempt to maintain blood pressure levels within 20 of baseline in most patients under anesthesia Maintaining the baseline blood pressure is important as patients may have pathology such as coronary artery disease carotid stenosis and renal artery stenosis and hypotension may compromise the perfusion of these organs Vasodilation also plays a key role in hypotension due to general anesthesia Therefore the intravenous IV administration of Ang II may be an effective treatment of hypotension in this patient populationThe objective of this study is to determine the infusion rate of Ang II that is necessary to return systolic blood pressure SBP to within 5 of baseline or greater in patients with essential hypertension taking ACE inhibitors ARBs or different classes of antihypertensive agents and further to determine the plasma levels of different RAAS components
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None