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Low enrollment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol | Drug | 2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John C. Stein, MD. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Normal Saline | Drug | 2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department. |
|
|
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |