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Trial record 6 of 1573 for:    giapreza

Angiotensin II in General Anesthesia

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ClinicalTrials.gov Identifier: NCT03733145
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Angiotensin II Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants on ACE inhibitors
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Drug: Angiotensin II
Participants in the ACE inhibitors, 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

Experimental: Participants on ARBs
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Drug: Angiotensin II
Participants in the ACE inhibitors, 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

Experimental: Other Classes of Antihypertensive Agents
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Drug: Angiotensin II
Participants in the ACE inhibitors, 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 Outcome Measures :
  1. Mean dose required to increase the SBP [ Time Frame: up to 1 hour ]
    The mean 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 Outcome Measures :
  1. Mean value of Bradykinin [ Time Frame: up to 1 hour ]
    Mean values of Bradykinin 1-8 and Bradykinin 1-7 will be calculated and reported.

  2. Mean value of Angiontensin [ Time Frame: up to 1 hour ]
    Mean values of Angiotensin I, Angiotensin II, Angiotensin IV, Angiotensin 1-7, Angiotensin 1-5, Angiotensin 1-9, Angiotensin 2-10, Angiotensin 2-7, and Angiotensin 3-7 will be calculated and reported.

  3. Mean value of Aldosterone [ Time Frame: up to 1 hour ]
    Mean value of Aldosterone will be calculated and reported.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733145


Contacts
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Contact: Rohesh Fernando, MD 3367162712 rfernan@wakehealth.edu
Contact: Thomas Templeton, MD 3367164285 ttemplet@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Rohesh Fernando, MD    336-716-2712    rfernan@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Rohesh Fernando, MD Wake Forest University Health Sciences
Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03733145    
Other Study ID Numbers: IRB00054661
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
Angiotensin II
Angiotensin Converting Enzyme Inhibitors
Angiotensin Receptor Blockers
Anesthesia-Mediated Hypotension
Additional relevant MeSH terms:
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Angiotensin II
Giapreza
Hypertension
Hypotension
Vascular Diseases
Cardiovascular Diseases
Angiotensinogen
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action