Nebulized Albuterol for Congestive Heart Failure Exacerbation (ACHE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01375361|
Recruitment Status : Withdrawn (Low enrollment.)
First Posted : June 17, 2011
Last Update Posted : October 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Drug: Albuterol Drug: Normal Saline||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||July 2010|
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.
- Borg Dyspnea Score [ Time Frame: 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.
- Admission [ Time Frame: An average of 48 hours ]If the patient is hospitalized we will continue to record information about their hospital stay and the patient will not receive more study interventions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375361
|United States, California|
|University of California|
|San Francisco, California, United States, 94143|
|Principal Investigator:||John C. Stein, MD.||University of California, San Francisco|