ACHE: Nebulized Albuterol for Congestive Heart Failure Exacerbation

Sponsor

University of California, San Francisco (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01375361

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Drug: Albuterol Drug: Normal Saline	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Albuterol 2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department. Other Names: 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 Names: Administration of Placebo.

Arm

Intervention/Treatment

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.

Drug: Albuterol

2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.

Other Names:

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 Names:

Administration of Placebo.

Outcome Measures

Primary Outcome Measures

Borg Dyspnea Score [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.

Secondary Outcome Measures

Admission [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California	San Francisco	California	United States	94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: John C. Stein, MD., University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01375361

Other Study ID Numbers:

RandomizedAlbuterolCHF

First Posted:

Jun 17, 2011

Last Update Posted:

Oct 10, 2013

Last Verified:

Oct 1, 2013

Keywords provided by University of California, San Francisco

albuterol

Additional relevant MeSH terms:

Heart Failure

Albuterol

Study Results

No Results Posted as of Oct 10, 2013