Nebulized Albuterol for Congestive Heart Failure Exacerbation (ACHE)

This study has been withdrawn prior to enrollment.
(Low enrollment.)
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01375361
First received: April 20, 2010
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure
Drug: Albuterol
Drug: Normal Saline
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Borg Dyspnea Score [ Time Frame: 8 hours. ] [ Designated as safety issue: No ]

    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:
  • Admission [ Time Frame: An average of 48 hours ] [ Designated as safety issue: No ]
    If the patient is hospitalized we will continue to record information about their hospital stay and the patient will not receive more study interventions.


Enrollment: 0
Study Start Date: April 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Albuterol
2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.
Other Name: Administration of Albuterol.
Placebo Comparator: 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.
Drug: Normal Saline
2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.
Other Name: Administration of Placebo.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375361

Locations
United States, California
University of California
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: John C. Stein, MD. University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01375361     History of Changes
Other Study ID Numbers: RandomizedAlbuterolCHF
Study First Received: April 20, 2010
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
albuterol

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 17, 2014