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临床试验/NCT04463394
NCT04463394已完成早期 1 期

The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology

Stanford University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年8月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
28
试验地点
2
主要终点
Change in systemic (aortic) blood pressure

研究概览

简要总结

The goal of this study is to evaluate if vasopressin can elevate systemic arterial blood pressures without having a significant effect on pulmonary arterial pressures. Because patients who have undergone Fontan procedures rely on low pressures across the pulmonary vascular bed to maintain cardiac output, vasoactive agents that concomitantly increase systemic and pulmonary pressures may have a deleterious effect in this specific patient population.

Hypothesis: In patients with Fontan physiology, vasopressin will increase systemic BP by 20% above baseline, without increasing the transpulmonary gradient.

详细描述

Patients with Fontan physiology are at increased risk of developing hypotension during periods of illness or with anesthesia. These patients have changes in venous capacitance, compliance, and venomotor tone. When hypotension occurs, the approach to management requires a careful understanding of these changes and the selection of appropriate, efficacious vasoactive agents. Vasoconstrictive medications are frequently used to treat hypotension when patients are refractory to fluid resuscitation. However, most of these medications have an effect on both the systemic and pulmonary circulations, raising the vascular pressures of both circuits. However, these patients often do not tolerate abrupt increases in pulmonary arterial pressures or vascular resistance, and a low transpulmonary gradient is imperative to maintain cardiac output. The ideal agent would be one that raises systemic vascular pressure while having a minimal effect on the pulmonary circulation.

One promising medication for treating hypotension in Fontan patients is vasopressin. One prior study evaluated the hemodynamic effect of vasopressin in pediatric patients with pulmonary hypertension. Compared to other vasopressor agents (phenylephrine, epinephrine), vasopressin increased systemic blood pressure with the least effect on pulmonary artery pressure. In a second study evaluating the use of vasopressin specifically for patients undergoing cardiac surgery for the creation of a Fontan, those who were treated with vasopressin as part of their postoperative management demonstrated lower transpulmonary gradients than those treated with placebo. Other studies have evaluated the use of vasopressin in Fontan patients for other clinical outcomes, such as decreasing postoperative chest tube output. On the basis of these studies, as well as our clinical experience managing these patients in the operating room, procedural suites, and in the intensive care unit, the investigator believes that vasopressin is not only safe but may be the preferred agent for this patient population.

Although vasopressin has been studied extensively in the context of sepsis, post cardiopulmonary bypass, and other vasoplegic disease states, the use of vasopressin has not yet been studied in the general population of patients who have Fontan physiology. The investigator hopes to demonstrate the efficacy of vasopressin as a medication specifically for these patients, as one that can elevate systemic blood pressure without compromising cardiac output or having a deleterious effect on the pulmonary vasculature.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients scheduled for cardiac catheterization at Lucile Packard Children's Hospital with Fontan circulation
  • Exclusion criteria:
  • Critical illness severe enough to preclude extended cardiac catheterization time
  • Patients already on vasopressin
  • Patients with pulmonary hypertension.
  • Patient not scheduled for cardiac catheterization at Lucile Packard Children's Hospital (LPCH).

排除标准

  • 未提供

研究组 & 干预措施

Vasopressin

Experimental

Participants undergoing cardiac catheterization

干预措施: Vasopressin (Drug)

结局指标

主要结局

Change in systemic (aortic) blood pressure

时间窗: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

Change in pulmonary artery pressure

时间窗: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

Change in transpulmonary gradient

时间窗: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

Transpulmonary gradient = Mean pulmonary arterial pressure - left atrial pressure

PVR/SVR Ratio

时间窗: Pre-dose, every 5 minutes post-dose for approximately 15 minutes (post-baseline values will be averaged)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manchula Navaratnam

Clinical Associate Professor, Anesthesiology

Stanford University

研究点 (2)

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