Nebulized Albuterol for Congestive Heart Failure Exacerbation (ACHE)
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.
Congestive Heart Failure
Drug: Normal Saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
- Borg Dyspnea Score [ Time Frame: 8 hours. ] [ Designated as safety issue: No ]
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.
- Admission [ Time Frame: An average of 48 hours ] [ Designated as safety issue: No ]If the patient is hospitalized we will continue to record information about their hospital stay and the patient will not receive more study interventions.
|Study Start Date:||April 2009|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: Inhaled Albuterol
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.
2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.
Other Name: Administration of Albuterol.
Placebo Comparator: Inhaled Placebo.
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
2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.
Other Name: Administration of Placebo.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375361
|United States, California|
|University of California|
|San Francisco, California, United States, 94143|
|Principal Investigator:||John C. Stein, MD.||University of California, San Francisco|