Nebulized Albuterol for Congestive Heart Failure Exacerbation

NCT ID: NCT01375361

Last Updated: 2013-10-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Albuterol

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

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

Interventions

Albuterol

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

Intervention Type: DRUG

Normal Saline

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

Intervention Type: DRUG

Other Intervention Names

Administration of Albuterol.; Administration of Placebo.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John C. Stein, MD.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California

San Francisco, California, United States

Countries

United States

Other Identifiers

RandomizedAlbuterolCHF

Identifier Type: -

Identifier Source: org_study_id