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临床试验/NCT03733145
NCT03733145已完成4 期

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

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年10月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
32
试验地点
1
主要终点
Median Dose Required to Increase the Systolic Blood Pressure (SBP)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Congestive heart failure
  • Chronic obstructive pulmonary disease
  • Pregnant patients

研究组 & 干预措施

Other Classes of Antihypertensive Agents

Experimental

Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.

干预措施: Angiotensin II (Drug)

Participants on ACE inhibitors

Experimental

Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.

干预措施: Angiotensin II (Drug)

Participants on ARBs

Experimental

Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.

干预措施: Angiotensin II (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Median Serum Level of Bradykinin 1-8(up to 1 hour)
  • Median Serum Level of Bradykinin 1-7(Up to 1 hour)
  • Median Serum Level of Bradykinin 1-5(Up to 1 hour)
  • Median Serum Level of Aldosterone(Up to 1 hour)
  • Median Serum Level of Angiotensin I(Up to 1 hour)
  • Median Serum Level of Angiotensin II(up to 1 hour)
  • Median Serum Level of Angiotensin IV(Up to 1 hour)
  • Median Serum Level of Angiotensin 1-7(Up to 1 hour)
  • Median Serum Level of Angiotensin 1-5(Up to 1 hour)
  • Median Serum Level of Angiotensin 1-9(Up to 1 hour)
  • Median Serum Level of Angiotensin 2-10(Up to 1 hour)
  • Median Serum Level of Angiotensin 2-7(Up to 1 hour)
  • Median Serum Level of Angiotensin 3-7(Up to 1 hour)
  • Median Serum Level of Angiotensin 1-12(Up to 1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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