Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT03733145
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.
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Notify Me40 year and older
All sexes
Interventional
Phase 4
Winston-Salem, North Carolina, 27157, United States
Hypotension in adult patients undergoing general anesthesia is common. Many of the body's 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 population.The 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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the ACE inhibitors, angiotensin-receptor blockers (ARBs), and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
Other names: Ang II, Giapreza
Time frame: up to 1 hour
The median dose required to increase the SBP in these 3 cohorts with essential hypertension (ACE inhibitor, ARB, or those on another class of hypertensive agents) to within 5% of baseline or higher will be calculated.
Time frame: up to 1 hour
Median serum level of Bradykinin 1-8
Time frame: Up to 1 hour
Median serum level of Bradykinin 1-7
Time frame: Up to 1 hour
Median serum level of Bradykinin 1-5
Time frame: Up to 1 hour
Median serum level of Aldosterone
Time frame: Up to 1 hour
Median serum level of Angiotensin I
Time frame: up to 1 hour
Median serum level of Angiotensin II
Time frame: Up to 1 hour
Median serum level of Angiotensin IV
Time frame: Up to 1 hour
Median serum level of Angiotensin 1-7
Time frame: Up to 1 hour
Median serum level of Angiotensin 1-5
Time frame: Up to 1 hour
Median serum level of Angiotensin 1-9
Time frame: Up to 1 hour
Median serum level of Angiotensin 2-10
Time frame: Up to 1 hour
Median serum level of Angiotensin 2-7
Time frame: Up to 1 hour
Median serum level of Angiotensin 3-7
Time frame: Up to 1 hour
Median serum level of Angiotensin 1-12
Wake Forest University Health Sciences
Other
A Dose Finding Trial for Angiotensin II in Hypertensive Adults on Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Anesthesia-Mediated Hypotension
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