Nebulized Albuterol for Congestive Heart Failure Exacerbation

NCT ID: NCT01375361

Last Updated: 2013-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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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

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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

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Congestive Heart Failure

Keywords

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albuterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

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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

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Administration of Albuterol. Administration of Placebo.

Eligibility Criteria

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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

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John C. Stein, MD.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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RandomizedAlbuterolCHF

Identifier Type: -

Identifier Source: org_study_id