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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014