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This study has been withdrawn prior to enrollment.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

April 20, 2010
October 9, 2013
April 2009
July 2010   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01375361 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Nebulized Albuterol for Congestive Heart Failure Exacerbation
Not Provided

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Congestive Heart Failure
  • Drug: Albuterol
    2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.
    Other Name: Administration of Albuterol.
  • Drug: Normal Saline
    2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.
    Other Name: Administration of Placebo.
  • 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.
    Intervention: Drug: 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.
    Intervention: Drug: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01375361
RandomizedAlbuterolCHF
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: John C. Stein, MD. University of California, San Francisco
University of California, San Francisco
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP