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Nebulized Albuterol for Congestive Heart Failure Exacerbation (ACHE)

Primary Purpose

Congestive Heart Failure

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Albuterol
Normal Saline
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring albuterol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inhaled Albuterol

Inhaled Placebo.

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
April 20, 2010
Last Updated
October 9, 2013
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01375361
Brief Title
Nebulized Albuterol for Congestive Heart Failure Exacerbation
Acronym
ACHE
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Low enrollment.
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
albuterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Albuterol
Arm Type
Experimental
Arm Description
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.
Arm Title
Inhaled Placebo.
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Albuterol
Other Intervention Name(s)
Administration of Albuterol.
Intervention Description
2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Administration of Placebo.
Intervention Description
2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.
Primary Outcome Measure Information:
Title
Borg Dyspnea Score
Description
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.
Time Frame
8 hours.
Secondary Outcome Measure Information:
Title
Admission
Description
If the patient is hospitalized we will continue to record information about their hospital stay and the patient will not receive more study interventions.
Time Frame
An average of 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Stein, MD.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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Nebulized Albuterol for Congestive Heart Failure Exacerbation

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