Nebulized Albuterol for Congestive Heart Failure Exacerbation (ACHE)

University of California San Francisco (UCSF)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Congestive Heart Failure

Treatments: Drug: Albuterol; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01375361

RandomizedAlbuterolCHF

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Inhaled Albuterol

Experimental group

Description:

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.

Treatment:

Drug: Albuterol

Inhaled Placebo.

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal Saline