Nebulized Albuterol for Congestive Heart Failure Exacerbation

Congestive Heart Failure Clinical Trial

— ACHE  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01375361
• Other study ID #: RandomizedAlbuterolCHF
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: April 20, 2010
• Last updated: October 9, 2013
• Start date: April 2009

Study information

• Verified date: October 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Albuterol
2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.
• Normal Saline
2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.

Locations

Country	Name	City	State
United States	University of California	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No