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临床试验/NCT01375361
NCT01375361撤回2 期

Nebulized Albuterol for Congestive Heart Failure Exacerbation

University of California, San Francisco1 个研究点 分布在 1 个国家开始时间: 2009年4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
撤回
试验地点
1
主要终点
Borg Dyspnea Score

研究概览

简要总结

This is a randomized trial of the use of Albuterol in the setting of acute decompensated Congestive Heart Failure with radiographic evidence of Cardiogenic Pulmonary Edema.

详细描述

The objective is to carry out a randomized blinded placebo-controlled trial of inhaled Albuterol as an early therapy for patients with decompensated Congestive Heart Failure. Compared to placebo, inhaled Albuterol will improve oxygenation and decrease the need for non-invasive ventilation in patients with Cardiogenic Pulmonary Edema.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

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

  • age 18-65 with shortness of breath and history of CHF
  • pulmonary edema on chest xr

排除标准

  • pregnancy
  • clinical or ekg changes to suggest acute coronary syndrome
  • history of copd or asthma
  • history of albuterol on medication list

研究组 & 干预措施

Inhaled Albuterol

Experimental

Patients identified to have Cardiogenic Pulmonary Edema, will receive 2.5mg of Albuterol nebulizer on enrollment in the study and again at 4 hours. Patients will be monitored on telemetry in the emergency department during and after study drug administration. Although study drug administration will cease after 4 hours, we will continue to record ongoing data during the patient's hospitalization.

干预措施: Albuterol (Drug)

Inhaled Placebo.

Placebo Comparator

Patients identified to have Cardiogenic Pulmonary Edema will receive 2.5mg Normal saline inhaled (Placebo) on enrollment and at 4 hours in the emergency department. Patient will be monitor on telemetry in the emergency department during and after placebo administration.

干预措施: Normal Saline (Drug)

结局指标

主要结局

Borg Dyspnea Score

时间窗: 8 hours.

Patients are evaluated for approximatly 8 hours with the Borg Dyspnea Score. Starting at the time of arrival, then one hour later and consequently every two hours until reaching 8 hours in total. The Borg score is used to quantify the degree of shortness of breath a person is experiencing which is a measured on a 10 point visual-analog scale.

次要结局

  • Admission(An average of 48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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