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Nebulized Albuterol for Congestive Heart Failure Exacerbation

Phase 2
Withdrawn
Conditions
Congestive Heart Failure
Interventions
Drug: Normal Saline
Registration Number
NCT01375361
Lead Sponsor
University of California, San Francisco
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Inhaled Placebo.Normal SalinePatients 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.
Inhaled AlbuterolAlbuterolPatients 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.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
AdmissionAn average of 48 hours

If the patient is hospitalized we will continue to record information about their hospital stay and the patient will not receive more study interventions.

Trial Locations

Locations (1)

University of California

🇺🇸

San Francisco, California, United States

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