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Nebulized Albuterol for Congestive Heart Failure Exacerbation

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01375361
Acronym
ACHE
Enrollment
0
Registered
2011-06-17
Start date
2009-04-30
Completion date
Unknown
Last updated
2013-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

albuterol

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.

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.

Interventions

DRUGAlbuterol

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

DRUGNormal Saline

2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Borg Dyspnea Score8 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

MeasureTime frameDescription
AdmissionAn average of 48 hoursIf the patient is hospitalized we will continue to record information about their hospital stay and the patient will not receive more study interventions.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026