A Phase 2/3 interventional study of Albuterol and Normal Saline in Congestive Heart Failure, sponsored by University of California, San Francisco. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-10-10.
Sponsored by University of California, San Francisco · Phase 2/3, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
Browse Heart Failure studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 Albuterol inhaled on enrollment and at 4 hours in the emergency department.
Also known as: Administration of Albuterol.
2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.
Also known as: Administration of Placebo.
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.
Time frame: 8 hours.
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.
Time frame: An average of 48 hours
This study is withdrawn, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco