Nebulized Albuterol for Congestive Heart Failure Exacerbation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: Albuterol
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-65 with shortness of breath and history of CHF pulmonary edema on chest xr Exclusion Criteria: pregnancy clinical or ekg changes to suggest acute coronary syndrome history of copd or asthma history of albuterol on medication list

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled Albuterol<br>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. | Drug: Albuterol<br>* 2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.<br>* Other names: Administration of Albuterol.;|
| Placebo Comparator: Inhaled Placebo.<br>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. | Drug: Normal Saline<br>* 2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.<br>* Other names: Administration of Placebo.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borg Dyspnea Score | 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. | 8 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission | If the patient is hospitalized we will continue to record information about their hospital stay and the patient will not receive more study interventions. | An average of 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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albuterol