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Completed

NCT Number: NCT03733145

Angiotensin II in General Anesthesia

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiotensin II

Drug

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

Primary outcomes

  1. Median Dose Required to Increase the Systolic Blood Pressure (SBP)

    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.

Secondary outcomes

  1. Median Serum Level of Bradykinin 1-8

    Time frame: up to 1 hour

    Median serum level of Bradykinin 1-8

  2. Median Serum Level of Bradykinin 1-7

    Time frame: Up to 1 hour

    Median serum level of Bradykinin 1-7

  3. Median Serum Level of Bradykinin 1-5

    Time frame: Up to 1 hour

    Median serum level of Bradykinin 1-5

  4. Median Serum Level of Aldosterone

    Time frame: Up to 1 hour

    Median serum level of Aldosterone

  5. Median Serum Level of Angiotensin I

    Time frame: Up to 1 hour

    Median serum level of Angiotensin I

  6. Median Serum Level of Angiotensin II

    Time frame: up to 1 hour

    Median serum level of Angiotensin II

  7. Median Serum Level of Angiotensin IV

    Time frame: Up to 1 hour

    Median serum level of Angiotensin IV

  8. Median Serum Level of Angiotensin 1-7

    Time frame: Up to 1 hour

    Median serum level of Angiotensin 1-7

  9. Median Serum Level of Angiotensin 1-5

    Time frame: Up to 1 hour

    Median serum level of Angiotensin 1-5

  10. Median Serum Level of Angiotensin 1-9

    Time frame: Up to 1 hour

    Median serum level of Angiotensin 1-9

  11. Median Serum Level of Angiotensin 2-10

    Time frame: Up to 1 hour

    Median serum level of Angiotensin 2-10

  12. Median Serum Level of Angiotensin 2-7

    Time frame: Up to 1 hour

    Median serum level of Angiotensin 2-7

  13. Median Serum Level of Angiotensin 3-7

    Time frame: Up to 1 hour

    Median serum level of Angiotensin 3-7

  14. Median Serum Level of Angiotensin 1-12

    Time frame: Up to 1 hour

    Median serum level of Angiotensin 1-12

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute on Aging (NIA)

Registry information

Official study title

A Dose Finding Trial for Angiotensin II in Hypertensive Adults on Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Anesthesia-Mediated Hypotension

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2018
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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