Clinical trial NCT03733145: Angiotensin II in General Anesthesia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Angiotensin II
Angiotensin Converting Enzyme Inhibitors
Angiotensin Receptor Blockers
Anesthesia-Mediated Hypotension
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute on Aging (NIA)
First posted: 2018-11-07
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility criteria: Inclusion Criteria:

* Diagnosis of hypertension and treatment with at least one medication including an ACE inhibitor, ARB, and other agents for greater than 2 months
* Patients undergoing general anesthesia

Exclusion Criteria:

* BMI \> 40
* History of deep venous thrombosis / thromboembolic disease
* History of stroke,
* Baseline SBP of ≥ 160 mmHg,
* History of myocardial infarction or cardiac stents
* Difficult airway
* Asthma
* Congestive heart failure
* Chronic obstructive pulmonary disease
* Pregnant patients

Primary outcomes:
measure: Mean dose required to increase the SBP
timeFrame: up to 1 hour
Secondary outcomes:
measure: Mean value of Bradykinin
timeFrame: up to 1 hour
measure: Mean value of Angiontensin
timeFrame: up to 1 hour
measure: Mean value of Aldosterone
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rohesh Fernando, MD
role: PRINCIPAL_INVESTIGATOR
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