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临床试验/NCT00237770
NCT00237770已完成2 期

Prevention of Low Blood Pressure in Persons With Tetraplegia

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2003年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
16
试验地点
1
主要终点
Systolic Blood Pressure During Head-up Tilt

研究概览

简要总结

The aim of this investigation is to determine the blood pressure response to NOS inhibition, with L-NAME, in persons with tetraplegia compared to non-SCI control subjects and to establish if blood pressure can be increased while upright in those with tetraplegia. If blood pressure is increased with NOS inhibition in persons with tetraplegia, this would improve our treatment of the condition of low blood pressure during seated postures in individuals with tetraplegia.

详细描述

Despite disruption of central command of the vasculature during orthostatic maneuvers, individuals with tetraplegia are generally able to be seated in an upright position for long periods of time without developing symptoms of orthostatic intolerance. It must be appreciated however, that orthostatic hypotension may occur unpredictably in persons with chronic tetraplegia. This may result in a range of symptoms due to cerebral hypoperfusion from mild reduction in mental acuity to loss of consciousness. Nitric oxide (NO) is the most potent endogenous vasodilator which is synthesized by the enzyme NO synthase (NOS) and may be largely responsible for orthostatic hypotension in individuals with immobilizing conditions. Recent evidence suggests an up-regulation of inducible nitric oxide synthases (NOS) activity with prolonged exposure to hind limb suspension. The effects of NOS inhibition during orthostasis on blood pressure regulation in those with chronic tetraplegia may provide insight into effective pharmacological therapy to reduce or prevent pathologic orthostatic changes. Treatment with a NOS inhibitor may facilitate the process of mobilization in those with acute higher cord lesions.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 65 year olds.
  • Non-ambulatory Chronic tetraplegia (1 year after acute SCI).

排除标准

  • central nervous system disease (other than SCI) e.g., multiple sclerosis, amyotrophic lateral sclerosis, syringomyelia, tabes dorsalis;
  • peripheral neuropathies;
  • surgical sympathectomy;
  • coronary heart and/or artery disease;
  • hypertension;
  • renal function abnormalities;
  • diabetes mellitus;
  • pituitary insufficiency;
  • adrenal insufficiency;
  • hypothyroidism; and
  • medications known to affect the cardiovascular system.

研究组 & 干预措施

Arm 1

Placebo Comparator

Placebo control (normal saline) is employed on a separate visit during procedure.

干预措施: N-Nitro L-arginine-methylester (L-NAME) (Drug)

Arm 1

Placebo Comparator

Placebo control (normal saline) is employed on a separate visit during procedure.

干预措施: Head-up Tilt maneuver (Procedure)

结局指标

主要结局

Systolic Blood Pressure During Head-up Tilt

时间窗: Average systolic blood pressure during head-up tilt (45 degrees) comparing active drug (L-NAME: 1.0 and 2.0 mg/kg) to placebo.

Average systolic blood pressure over 45 minutes at 45 degrees of head-up tilt.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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